86 FR 55 pgs. 15686-15691 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 86Number: 55Pages: 15686 - 15691
Pages: 15686, 15687, 15688Docket number: [Docket Nos. FDA–2018–M–3841, FDA–2018–M–3842, FDA–2018–M–3983, FDA–2018–M–4033, FDA–2018–M–4205, FDA–2018–M–4580, FDA–2018–M–4582, FDA–2018–M–4665, FDA–2018–M–4777, FDA–2018–M–4778, FDA–2018–M–4779, FDA–2018–M–4780, FDA–2018–M–4916, FDA–2019–M–0027, FDA–2019–M–0028, FDA–2019–M–0505, FDA–2019–M–0645, FDA–2019–M–0802, FDA–2019–M–0885, FDA–2019–M–0995, FDA–2019–M–1214, FDA–2019–M–1251, FDA–2019–M–1310, FDA–2019–M–1313, FDA–2019–M–1465, FDA–2019–M–1506, FDA–2019–M–1582, FDA–2019–M–1763, FDA–2019–M–1848, FDA–2019–M–1979, FDA–2019–M–1998, FDA–2019–M–2052, FDA–2019–M–2193, FDA–2019–M–2408, FDA–M–2522, FDA–2019–M–2560, FDA–2019–M–2561, FDA–2019–M–2671, FDA–2019–M–2732, FDA–2019–M–2753, FDA–2019–M–2782, FDA–2019–M–3309, FDA–2019–M–3513, FDA–2019–M–3652, FDA–2019–M–3845, FDA–2019–M–3863, FDA–2019–M–3844, FDA–2019–M–4007, FDA–2019–M–4153, FDA–2019–M–4186, FDA–2019–M–4238, FDA–2019–M–4928, FDA–2019–M–4978, FDA–2019–M–5393, FDA–2019–M–5438, FDA–2019–M–5534, FDA–2019–M–5605, FDA–2019–M–5683, FDA–2019–M–5741, FDA–2019–M–5857, FDA–2019–M–5961, FDA–2020–M–0097, FDA–2020–M–0107, FDA–2020–M–0108, FDA–2020–M–0495, FDA–2020–M–0985, FDA–2020–M–0984, FDA–2020–M–0986, FDA–2020–M–1083, FDA–2020–M–1115, FDA–2020–M–1116, FDA–2020–M–1175, FDA–2020–M–1213, FDA–2020–M–1214, FDA–2020–M–1267, FDA–2020–M–1286, FDA–2020–M–1290, FDA–2020–M–1299, FDA–2020–M–1300, FDA–2020–M–1311, FDA–2020–M–1358, FDA–2020–M–1367, FDA–2020–M–1410, FDA–2020–M–1420, FDA–2020–M–1527, FDA–2020–M–1583, FDA–2020–M–1600, FDA–2020–M–1612, FDA–2020–M–1613, FDA–2020–M–1715, FDA–2020–M–1724, FDA–2020–M–1726, FDA–2020–M–1748, FDA–2020–M–1752, FDA–2020–M–1760, FDA–2020–M–1821, FDA–2020–M–1783, FDA–2020–M–1822, FDA–2020–M–1828, FDA–2020–M–1830, FDA–2020–M–1829, FDA–2020–M–1835, FDA–2020–M–1838, FDA–2020–M–1868, FDA–2020–M–1986, FDA–2020–M–2021, FDA–2020–M–2288, FDA–2020–M–2248, and FDA–2020–M–2339]
FR document: [FR Doc. 2021–06052 Filed 3–23–21; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-2018-M-4665, FDA-2018-M-4777, FDA-2018-M-4778, FDA-2018-M-4779, FDA-2018-M-4780, FDA-2018-M-4916, FDA-2019-M-0027, FDA-2019-M-0028, FDA-2019-M-0505, FDA-2019-M-0645, FDA-2019-M-0802, FDA-2019-M-0885, FDA-2019-M-0995, FDA-2019-M-1214, FDA-2019-M-1251, FDA-2019-M-1310, FDA-2019-M-1313, FDA-2019-M-1465, FDA-2019-M-1506, FDA-2019-M-1582, FDA-2019-M-1763, FDA-2019-M-1848, FDA-2019-M-1979, FDA-2019-M-1998, FDA-2019-M-2052, FDA-2019-M-2193, FDA-2019-M-2408, FDA-M-2522, FDA-2019-M-2560, FDA-2019-M-2561, FDA-2019-M-2671, FDA-2019-M-2732, FDA-2019-M-2753, FDA-2019-M-2782, FDA-2019-M-3309, FDA-2019-M-3513, FDA-2019-M-3652, FDA-2019-M-3845, FDA-2019-M-3863, FDA-2019-M-3844, FDA-2019-M-4007, FDA-2019-M-4153, FDA-2019-M-4186, FDA-2019-M-4238, FDA-2019-M-4928, FDA-2019-M-4978, FDA-2019-M-5393, FDA-2019-M-5438, FDA-2019-M-5534, FDA-2019-M-5605, FDA-2019-M-5683, FDA-2019-M-5741, FDA-2019-M-5857, FDA-2019-M-5961, FDA-2020-M-0097, FDA-2020-M-0107, FDA-2020-M-0108, FDA-2020-M-0495, FDA-2020-M-0985, FDA-2020-M-0984, FDA-2020-M-0986, FDA-2020-M-1083, FDA-2020-M-1115, FDA-2020-M-1116, FDA-2020-M-1175, FDA-2020-M-1213, FDA-2020-M-1214, FDA-2020-M-1267, FDA-2020-M-1286, FDA-2020-M-1290, FDA-2020-M-1299, FDA-2020-M-1300, FDA-2020-M-1311, FDA-2020-M-1358, FDA-2020-M-1367, FDA-2020-M-1410, FDA-2020-M-1420, FDA-2020-M-1527, FDA-2020-M-1583, FDA-2020-M-1600, FDA-2020-M-1612, FDA-2020-M-1613, FDA-2020-M-1715, FDA-2020-M-1724, FDA-2020-M-1726, FDA-2020-M-1748, FDA-2020-M-1752, FDA-2020-M-1760, FDA-2020-M-1821, FDA-2020-M-1783, FDA-2020-M-1822, FDA-2020-M-1828, FDA-2020-M-1830, FDA-2020-M-1829, FDA-2020-M-1835, FDA-2020-M-1838, FDA-2020-M-1868, FDA-2020-M-1986, FDA-2020-M-2021, FDA-2020-M-2288, FDA-2020-M-2248, and FDA-2020-M-2339]
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from October 1, 2018, through December 31, 2020. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
ADDRESSES:
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see "Written/Paper Submissions" and "Instructions").
Written/Paper Submissions
Submit written/paper submissions as follows:
• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in "Instructions."
[top] Instructions: All submissions received must include the Docket Nos. FDA-2018-M-3841, FDA-2018-M-3842, FDA-2018-M-3983, FDA-2018-M-4033, FDA-2018-M-4205, FDA-2018-M-4580, FDA-2018-M-4582, FDA-
• Confidential Submissions-To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states "THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION." The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as "confidential." Any information marked as "confidential" will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the "Search" box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
Dharmesh Patel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-3289.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under §?10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is published in the Federal Register . Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.
The regulations provide that FDA publish a list of available safety and effectiveness summaries of PMA approvals and denials that were announced. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the internet from October 1, 2018, through December 31, 2020. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.
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| PMA No., Docket No. | Applicant | Trade name | Approval date |
|---|---|---|---|
| P180003, FDA-2018-M-3841 | Veryan Medical Ltd | BioMimics 3D Vascular Stent System | 10/4/2018 |
| P150040/S003, FDA-2018-M-3842 | Carl Zeiss Meditec, Inc | VisuMax Femtosecond Laser | 10/4/2018 |
| P160054/S008, FDA-2018-M-3983 | Thoratec Corp | HeartMate 3 Left Ventricular Assist System | 10/18/2018 |
| P100040/S036, FDA-2018-M-4033 | Medtronic Vascular | Valiant Navion TM Thoracic Stent Graft System | 10/19/2018 |
| P180010, FDA-2018-M-4205 | W.L. Gore & Associates, Inc | GORE Carotid Stent | 11/1/2018 |
| P150002, FDA-2018-M-4580 | Cordis Corp | Cordis INCRAFT® AAA Stent Graft System | 11/27/2018 |
| P120016/S024, FDA-2018-M-4582 | Cardiva Medical, Inc | VASCADE® MVP Venous Vascular Closure System | 11/27/2018 |
| P180007, FDA-2018-M-4665 | Spiration, Inc | Spiration® Valve System | 12/3/2018 |
| P160034, FDA-2018-M-4672 | Cardiac Science Corp | Powerheart® G3 Pro AED | 12/6/2018 |
| P160033, FDA-2018-M-4675 | Cardiac Science Corp | Powerheart® G5 AED, Powerheart® AED G3 Plus, And Powerheart® AED G3 | 12/7/2018 |
| P160043/S012, FDA-2018-M-4777 | Medtronic Vascular | Resolute Onyx TM Zotarolimus-Eluting Coronary Stent System | 12/14/2018 |
| P110013/S088, FDA-2018-M-4778 | Medtronic Vascular | Resolute Integrity Zotarolimus-Eluting Coronary Stent System | 12/14/2018 |
| P100018/S015, FDA-2018-M-4779 | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Pipeline TM Flex Embolization Device | 12/14/2018 |
| P150038/S006, FDA-2018-M-4780 | InSightec, Inc | Exablate Model 4000 Types 1.0 and 1.1 System (Exablate Neuro) | 12/16/2018 |
| P170018, FDA-2018-M-4916 | Physio-Control, Inc | LIFEPAK® CR2 Defibrillator | 12/21/2018 |
| P170032, FDA-2019-M-0027 | Sequent Medical, Inc | Woven EndoBridge (WEB) Aneurysm Embolization System | 12/31/2018 |
| P180001, FDA-2019-M-0028 | William Cook Europe ApS | Zenith® Dissection Endovascular System | 12/31/2018 |
| P170037, FDA-2019-M-0505 | OPKO Diagnostics, LLC | Sangia Total PSA Test | 1/30/2019 |
| P180025, FDA-19M-2526 | Essential Medical, Inc | MANTA TM Vascular Closure Device | 2/1/2019 |
| P170036, FDA-2019-M-0645 | Spinal Kinetics LLC | M6-C TM Artificial Cervical Disc | 2/6/2019 |
| P160050, FDA-2019-M-0802 | Intrinsic Therapeutics | Barricaid® Anular Closure Device (ACD) | 2/8/2019 |
| P170030, FDA-2019-M-0885 | Biotronik, Inc | Orsiro Sirolimus Eluting Coronary Stent System (Orsiro Stent System) | 2/22/2019 |
| P170042/S002, FDA-2019-M-0995 | C.R. Bard, Inc | COVERA TM Vascular Covered Stent | 3/1/2019 |
| P160002/S009, FDA-2019-M-1310 | Ventana Medical System, Inc | VENTANA PD-L1 (SP142) Assay | 3/8/2019 |
| P180037, FDA-2019-M-1214 | Bard Peripheral Vascular, Inc. (BPV) | VENOVO Venous Stent System | 3/13/2019 |
| P100009/S028, FDA-2019-M-1251 | Abbott Vascular, Inc | MitraClip NT Clip Delivery System; MitraClip NTR/XTR Clip Delivery System | 3/14/2019 |
| P180036, FDA-2019-M-1313 | Impulse Dynamics (USA), Inc | OPTIMIZER Smart System | 3/21/2019 |
| P180040, FDA-2019-M-1465 | Fidia Pharma USA, Inc | TRILURON TM | 3/26/2019 |
| P180032, FDA-2019-M-1506 | Channel Medsystems, Inc | Cerene® Cryotherapy Device | 3/28/2019 |
| P170027, FDA-2019-M-1582 | TherOx, Inc | TherOx DownStream System | 4/2/2019 |
| P180034, FDA-2019-M-1763 | Intact Vascular, Inc | Tack Endovascular System® (6F) | 4/11/2019 |
| P180043, FDA-2019-M-1979 | QIAGEN Manchester Ltd | therascreen ® FGFR RGQ RT-PCR Kit | 4/12/2019 |
| P180024, FDA-2019-M-1848 | BAROnova, Inc | TransPyloric Shuttle/TransPyloric Shuttle Delivery Device | 4/16/2019 |
| P180029, FDA-2019-M-1998 | Boston Scientific Corp | LOTUS Edge TM Valve System | 4/23/2019 |
| P180014, FDA-2019-M-2052 | XVIVO Perfusion, Inc | XVIVO Perfusion System (XPS TM ) with STEEN Solution TM Perfusate | 4/26/2019 |
| P180013, FDA-2019-M-2193 | Boston Scientific Corp | VICI VENOUS STENT® System | 5/2/2019 |
| P180031, FDA-2019-M-2408 | Stryker Neurovascular | Neuroform Atlas® Stent System | 5/16/2019 |
| H180002, FDA-2019-M-2522 | Novocure, Ltd | NovoTTF TM -100L System | 5/23/2019 |
| P190001, FDA-2019-M-2560 | QIAGEN GmbH | therascreen PIK3CA RGQ PCR Kit | 5/24/2019 |
| P190004, FDA-2019-M-2561 | QIAGEN GmbH | therascreen PIK3CA RGQ PCR Kit | 5/24/2019 |
| P160013/S002, FDA-2019-M-2671 | TransMedics, Inc | Organ Care System (OCS TM ) Lung System | 5/31/2019 |
| P160036, FDA-2019-M-2732 | DT MedTech, LLC | Hintermann Series H3 TM Total Ankle Replacement System | 6/4/2019 |
| P160048/S006, FDA-2019-M-2753 | Senseonics, Inc | Eversense Continuous Glucose Monitoring System | 6/6/2019 |
| P160029, FDA-2019-M-2782 | Philips Medical Systems, Inc | HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A) | 6/6/2019 |
| P150013/S014, FDA-2019-M-3309 | Dako North America, Inc | PD-L1 IHC 22C3 pharmDx | 6/10/2019 |
| P000025/S104, FDA-2019-M-3513 | MED-EL Corp | MED-EL Cochlear Implant System | 7/19/2019 |
| P150013/S016, FDA-2019-M-3652 | Dako North America, Inc | PD-L1 1HC 22C3 pharmDx | 7/30/2019 |
| P140031/S085, FDA-2019-M-3845 | Edwards Lifesciences LLC | Edwards SAPIEN 3 Transcatheter Heart Valve System and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System | 8/16/2019 |
| H190005, FDA-2019-M-3863 | Zimmer Biomet Spine, Inc | The Tether TM -Vertebral Body Tethering System | 8/16/2019 |
| P180050, FDA-2019-M-3862 | CVRx, Inc | BAROSTIM NEO® System | 8/16/2019 |
| P130021/S058, FDA-2019-M-3844 | Medtronic CoreValve LLC | Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System | 8/16/2019 |
| H170001, FDA-2019-M-4007 | ApiFix, Ltd | Minimally Invasive Deformity Correction (MID-C) System | 8/23/19 |
| P040020/S087, FDA-2019-M-4153 | Alcon Laboratories, Inc | AcrySof® IQ PanOptix® Trifocal Intraocular Lens (Model TFNT00) and AcrySof® IQ PanOptix® Toric Trifocal Intraocular Lens (Models TFNT30, TFNT40, TFNT50 and TFNT60) | 8/26/2019 |
| P190006, FDA-2019-M-4186 | Axonics Modulation Technologies, Inc | Axonics Sacral Neuromodulation System | 9/6/2019 |
| P930016/S057, FDA-2019-M-4238 | AMO Manufacturing USA, LLC | iDESIGN® Refractive Studio and STAR S4 IR® Excimer Laser Systems | 9/9/2019 |
| P190011, FDA-2019-M-4928 | DiaSorin Inc | LIAISON XL MUREX HCV Ab LIAISON XL MUREX Control HCV Ab | 10/18/2019 |
| P190014, FDA-2019-M-4978 | Myriad Genetic Laboratories, Inc | Myriad myChoice® CDx | 10/23/2019 |
| P180046, FDA-2019-M-5393 | Axonics Modulation Technologies, Inc | Axonics Sacral Neuromodulation System | 11/13/2019 |
| P180035, FDA-2019-M-5438 | CooperVision, Inc | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear | 11/15/2019 |
| P190008, FDA-2019-M-5534 | Medtronic, Inc | IN.PACT TM AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | 11/21/2019 |
| P190016, FDA-2019-M-5605 | Tusker Medical, Inc | Tula® System | 11/25/2019 |
| P180047, FDA-2019-M-5683 | DiaSorin, Inc | LIAISON QuantiFERON-TB Gold Plus, LIAISON Control QuantiFERON-TB Gold Plus and LIAISON QuantiFERON Software | 11/26/2019 |
| P170019/S006, FDA-2019-M-5741 | Foundation Medicine, Inc | FoundationOne® CDx | 12/3/2019 |
| P170038, FDA-2019-M-5857 | Abbott | CentriMag Circulatory Support System | 12/6/2019 |
| P180027, FDA-2019-M-5961 | MicroVention, Inc | Flow Re-Direction Endoluminal Device (FRED®) System | 12/16/2019 |
| P140009/S039, FDA-2020-M-0097 | Abbott Medical, Inc | Abbott Infinity TM DBS System | 1/2/2020 |
| P180038, FDA-2020-M-0107 | DiaSorin, Inc | LIAISON® XL MUREX Anti-HBc, LIAISON® XL MUREX Control Anti-HBc | 1/2/2020 |
| P190018, FDA-2020-M-0108 | Alcon Research, Inc | Clareon TM Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (Model Number: SY60WF); Clareon TM Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) (Model Numbers: CNW0T3, CNW0T4, CNW0T5, CNW0T6, CNW0T7, CNW0T8 and CNW0T9); Clareon TM Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMe TM Pre-loaded Delivery System (Model Number: CNA0T0); Clareon TM Toric Aspheric Hydrophobic Acrylic Intraocular Lens (IOL) with the AutonoMe TM Pre-loaded Delivery System (Model Numbers: CNA0T3, CNA0T4, CNA0T5, CNA0T6, CNA0T7, CNA0T8 and CNA0T9) | 1/7/2020 |
| P170023, FDA-2020-M-0495 | Contura International A/S | Bulkamid® Urethral Bulking System | 1/28/2020 |
| P170022, FDA-2020-M-0985 | ARJ Medical, Inc | PyloPlus UBT System | 2/18/2020 |
| P180039, FDA-2020-M-0984 | DiaSorin Inc | LIAISON® XL MUREX Anti-HBs; LIAISON® XL MUREX Control Anti-HBs; LIAISON® XL MUREX Anti-HBs Verifiers | 2/21/2020 |
| P930014/S126, FDA-2020-M-0986 | Alcon Laboratories, Inc | AcrySof TM IQ Vivity TM Extended Vision Intraocular Lens (Model DFT015); AcrySof TM IQ Vivity TM Toric Extended Vision IOLs (DFT315, DFT 415, DFT515); AcrySof TM IQ Vivity TM Extended Vision UV Absorbing IOL (DAT015); AcrySof TM IQ Vivity TM Toric Extended Vision UV Absorbing IOLs (DAT315, DAT415, DAT515) | 2/26/2020 |
| P190024, FDA-2020-M-1083 | Ventana Medical Systems, Inc | CINtec® PLUS Cytology | 3/10/2020 |
| P120006/S031, FDA-2020-M-1126 | Endologix, Inc | Alto TM Abdominal Stent Graft System | 3/13/2020 |
| P980033/S050, FDA-2020-M-1115 | Boston Scientific Corp | VENOUS WALLSTENT | 3/17/2020 |
| P970051/S172, FDA-2020-M-1116 | Cochlear Americas | Nucleus 24 Cochlear Implant System | 3/17/2020 |
| P190025, FDA-2020-M-1175 | Abbott Molecular, Inc | Alinity m HCV | 3/23/2020 |
| P140029/S021, FDA-2020-M-1214 | Q-Med AB, a Galderma affiliate | Restylane® Kysse | 3/26/2020 |
| P190028, FDA-2020-M-1213 | Roche Molecular Systems, Inc | cobas HPV for use on the cobas 6800/8800 Systems | 4/3/2020 |
| P190027, FDA-2020-M-1286 | Intact Vascular, Inc | Tack Endovascular System® (4F, 1.5-4.5mm) | 4/10/2020 |
| P050010/S020, FDA-2020-M-1267 | Centinel Spine, LLC | prodisc® L Total Disc Replacement | 4/10/2020 |
| P130008/S039, FDA-2020-M-1299 | Inspire Medical Systems, Inc | Inspire® Upper Airway Stimulation (UAS) | 4/14/2020 |
| P190026, FDA-2020-M-1290 | QIAGEN GmbH | therascreen® BRAF V600E RGQ PCR Kit | 4/15/2020 |
| P170019/S013, FDA-2020-M-1300 | Foundation Medicine, Inc | FoundationOne® CDx (F1CDx) | 4/17/2020 |
| P190015, FDA-2020-M-1311 | Bolton Medical Inc | TREO® Abdominal Stent-Graft System | 5/4/2020 |
| P170019/S011, FDA-2020-M-1358 | Foundation Medicine, Inc | FoundationOne® CDx (F1CDx) | 5/6/2020 |
| P160028, FDA-2020-M-1367 | Philips Medical Systems, Inc | HeartStart FR3 Defibrillators Models 861388 (Text) and 861389 (ECG Display), Primary Battery (Models 989803150161, 989803150171), Rechargeable Battery (Model 989803150241), Charger for the Rechargeable Battery (Model 861394), SmartPads III (Models 989803149981, 989803149991), DP pads (Models 989803158211, 989803158221), and Pediatric Key (Model 989803150031) | 5/11/2020 |
| P180028, FDA-2020-M-1368 | Philips Medical Systems, Inc | HeartStart FRx Defibrillator (861304), Primary Battery (M5070A), Aviation FRx Battery (989803139301), SMART Pads II (989803139261), and Infant/Child Key (989803139311) | 5/11/2020 |
| P150025/S013, FDA-2020-M-1410 | Dako North America, Inc | PD-L1 IHC 28-8 pharmDx | 5/15/2020 |
| P170019/S015, FDA-2020-M-1420 | Foundation Medicine, Inc | FoundationOne® CDx | 5/19/2020 |
| P110033/S047, FDA-2020-M-1527 | Allergan | JUVÉDERM® VOLUMA TM XC | 6/12/2020 |
| P190021, FDA-2020-M-1583 | Mainstay Medical Ltd | ReActiv8 Implantable Neurostimulation System | 6/16/2020 |
| P170019/S016, FDA-2020-M-1612 | Foundation Medicine, Inc | FoundationOne® CDx (F1CDx) | 6/16/2020 |
| P200014, FDA-2020-M-1600 | Roche Molecular Systems, Inc | cobas® EZH2 Mutation Test | 6/18/2020 |
| P100010/S098, FDA-2020-M-1613 | Medtronic, Inc | Arctic Front Advance TM Cardiac Cryoablation Catheter Arctic Front Advance Pro TM Cardiac Cryoablation Catheters Freezor TM MAX Cardiac Cryoablation Catheter CryoConsole Manual Retraction Kit | 6/23/2020 |
| P130013/S035, FDA-2020-M-1715 | Boston Scientific Corp | WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device with Delivery System | 7/21/2020 |
| P190031, FDA-2020-M-1724 | Ventana Medical Systems, Inc | VENTANA HER2 Dual ISH DNA Probe Cocktail | 7/28/2020 |
| P180031/S001, FDA-2020-M-1726 | Stryker Neurovascular | Neuroform Atlas® Stent System | 7/30/2020 |
| P200010, FDA-2020-M-1748 | Guardant Health, Inc | Guardant360® CDx | 8/7/2020 |
| P190007, FDA-2020-M-1752 | Cardinal Health | Kendall TM Multi-Function Defibrillation Electrodes, Medi-Trace TM Cadence Multi-Function Defibrillation Electrodes, Physio-Control/Stryker QUIK-COMBO Pacing/Defibrillation/ECG Electrodes | 8/7/2020 |
| P150003/S058, FDA-2020-M-1760 | Boston Scientific Corp | SYNERGY TM Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail TM ); SYNERGY TM Everolimus-Eluting Platinum Chromium Coronary Stent System (Over-The-Wire TM ); SYNERGY TM XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail TM ) | 8/10/2020 |
| P190032, FDA-2020-M-1821 | Foundation Medicine, Inc | FoundationOne Liquid CDx | 8/26/2020 |
| P180048, FDA-2020-M-1783 | Diasorin, Inc | LIAISON® XL MUREX HBeAg, LIAISON® XL MUREX Control HBeAg | 8/29/2020 |
| P180049, FDA-2020-M-1822 | Diasorin, Inc | LIAISON® XL MUREX anti-HBe, LIAISON® XL MUREX Control Anti-HBe | 8/29/2020 |
| P180045, FDA-2020-M-1828 | Diasorin, Inc | LIAISON® XL MUREX HBc IgM, LIAISON® XL MUREX Control HBc IgM | 8/29/2020 |
| P200013, FDA-2020-M-1830 | Abbott Molecular, Inc | Alinity m HBV | 8/29/2020 |
| P190017, FDA-2020-M-1829 | Diasorin, Inc | LIAISON® XL MUREX HBsAg Qual; LIAISON® MUREX Control HBsAg Qual; LIAISON® XL MUREX HBsAg Confirmatory Test | 8/29/2020 |
| P200015, FDA-2020-M-1835 | Edwards Lifesciences, LLC | Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System | 8/31/2020 |
| P160017/S076, FDA-2020-M-1838 | Medtronic Minimed, Inc | MiniMed 770G System | 8/31/2020 |
| P140031/S112, FDA-2020-M-1868 | Edwards Lifesciences, LLC | Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System | 9/9/2020 |
| P200022, FDA-2020-M-1986 | Simplify Medical, Inc | Simplify® Cervical Artificial Disc | 9/18/2020 |
| P160042/S010, FDA-2020-M-2021 | Prollenium Medical Technologies, Inc | Revanesse® Lips+ | 9/21/2020 |
| H190001, FDA-2020-M-2248 | HDL Therapeutics, Inc | Plasma Delipidation System (PDS-2 TM System) | 12/1/2020 |
| P190030, FDA-2020-M-2288 | Theragen, Inc | ActaStim-S Spine Fusion Stimulator | 12/9/20 |
| P200030, FDA-2020-M-2339 | W. L. Gore and Associates, Inc | GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) | 12/22/20 |
II. Electronic Access
Persons with access to the internet may obtain the documents at https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: March 15, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06052 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P