Rules and Regulations. Notice
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/register/2016/02/09/2016-02522A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-P 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. • 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 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: *http://www.fda.gov/regulatoryinformation/dockets/default.htm.* *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. Table 1—List of Safety and Effectiveness Summaries for Approved PMAs Made Available From October 1, 2015, Through December 31, 2015 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]
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