81 FR 26 pgs. 6865-6866 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
Type: NOTICEVolume: 81Number: 26Pages: 6865 - 6866
Pages: 6865, 6866Docket number: [Docket Nos. FDA-2015-M-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-2015-M-3376, FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-2015-M-3519, FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-2015-M-4014, FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-2015-M-4018, FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-2015-M-4434, FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951]
FR document: [FR Doc. 2016-02522 Filed 2-8-16; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
[top]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2015-M-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-2015-M-3376, FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-2015-M-3519, FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-2015-M-4014, FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-2015-M-4018, FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-2015-M-4434, FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951]
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) is publishing a list of premarket approval applications (PMAs) that have been approved. 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 Division of Dockets Management.
ADDRESSES:
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, 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."
Instructions: All submissions received must include the Docket Nos. FDA-2015-M-3256, FDA-2015-M-3257, FDA-2015-M-3258, FDA-2015-M-3376, FDA-2015-M-3377, FDA-2015-M-3516, FDA-2015-M-3516, FDA-2015-M-3519, FDA-2015-M-3520, FDA-2015-M-3521, FDA-2015-M-4013, FDA-2015-M-4014, FDA-2015-M-4015, FDA-2015-M-4016, FDA-2015-M-4017, FDA-2015-M-4018, FDA-2015-M-4069, FDA-2015-M-4343, FDA-2015-M-4344, FDA-2015-M-4434, FDA-2015-M-4728, FDA-2015-M-4947, and FDA-2015-M-4951 for "Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications." Received comments will be placed in the docket and, except for those submitted as "Confidential Submissions," publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
[top] • 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 http://www.regulations.gov. Submit both copies to the Division of Dockets Management. 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
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the 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 placed on the Internet. 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 quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from October 1, 2015, through December 31, 2015. 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.
| PMA No., Docket No. | Applicant | Trade name | Approval date |
|---|---|---|---|
| P150010, FDA-2015-M-3256 | Fidia Farmaceutici, S.p.A. | HYMOVIS® | 8/28/2015 |
| P100006, FDA-2015-M-3257 | Biomimetic Therapeutics, LLC | Augment® Bone Graft | 9/1/2015 |
| P140005, FDA-2015-M-3258 | OrthogenRx, Inc. | GenVisc 850® | 9/2/2015 |
| P140015, FDA-2015-M-3376 | Tandem Diabetes Care, Inc. | t:slim G4 Insulin Pump With Dexcom G4 Platinum CGM | 9/8/2015 |
| P140016, FDA-2015-M-3377 | Cook Medical Inc. | Zenith Alpha Thoracic Endovascular Graft | 9/15/2015 |
| P070015/S128, FDA-2015-M-3516 | Abbott Vascular | XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent System | 9/23/2015 |
| P110019/S075, FDA-2015-M-3516 | Abbott Vascular | XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System, XIENCE Xpedition, XIENCE Xpedition SV and XIENCE Xpedition LL Everolimus Eluting Coronary Stent System, and XIENCE Alpine Everolimus Eluting Coronary Stent System | 9/23/2015 |
| P050047/S044, FDA-2015-M-3519 | Allergan | Juvéderm Ultra XC injectable gel | 9/30/2015 |
| P120010/S046, FDA-2015-M-4013 | Medtronic, Inc. | MiniMed 530G System with Threshold Suspend featuring SmartGuard TM technology | 10/2/2015 |
| P150003, FDA-2015-M-4014 | Boston Scientific Corporation | SYNERGY TM Everolimus-Eluting Platinum Chromium Coronary Stent System | 10/2/2015 |
| P150013, FDA-2015-M-3520 | Dako North America, Inc. | PD-L1 IHC 22C3 pharmDx | 10/2/2015 |
| P100034/S013, FDA-2015-M-4015 | Novocure, Ltd. | Optune TM (Formerly the NovoTTF-100A System) | 10/5/2015 |
| P150025, FDA-2015-M-4016 | Dako North America, Inc. | PD-L1 IHC 28-8 pharmDx | 10/9/2015 |
| P130009/S034, FDA-2015-M-4017 | Edwards Lifesciences, LLC | Edwards SAPIEN XT TM Transcatheter Heart Valve, model 9300TFX, and Accessories | 10/9/2015 |
| P150014, FDA-2015-M-4069 | Roche Molecular Systems, Inc. | cobas® HBV | 10/14/2015 |
| P150015, FDA-2015-M-4018 | Roche Molecular Systems, Inc. | cobas® HCV | 10/14/2015 |
| P140019, FDA-2015-M-4343 | Cerapedics, Inc. | i-FACTOR TM Peptide Enhanced Bone Graft | 11/3/2015 |
| P120019/S007, FDA-2015-M-4344 | Roche Molecular Systems, Inc. | cobas® EGFR Mutation Test v2 | 11/13/2015 |
| P130028, FDA-2015-M-4434 | Algostim, LLC | Algovita Spinal Cord Stimulation System | 11/20/2015 |
| P150019, FDA-2015-M-4728 | Medtronic MiniMed | Paradigm Real-Time Revel System | 12/7/2015 |
| P010030/S056, FDA-2015-M-3521 | ZOLL Manufacturing Corporation | LifeVest Wearable Cardioverter Defibrillator Models 3000, 3100, and 4000 | 12/17/2015 |
| P140030, FDA-2015-M-4947 | Biotronik, Inc. | Astron Peripheral Self-Expanding Nitinol Stent System | 12/17/2015 |
| P980044/S027, FDA-2015-M-4951 | Seikagaku Corporation | VISCO-3 TM | 12/21/2015 |
II. Electronic Access
Persons with access to the Internet may obtain the documents at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.
Dated: February 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-02522 Filed 2-8-16; 8:45 am]
BILLING CODE 4164-01-P