FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM

FDA Premarket Approval P100028 S004

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a labeling update based on the post-approval study results.

• Device: FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM
• Generic Name: Stent, Renal
• Applicant: COOK MEDICAL INCORPORATED
• Date Received: 2013-09-20
• Decision Date: 2014-10-08
• PMA: P100028
• Supplement: S004
• Product Code: NIN
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Pas
• Expedited Review: No
• Combination Product: No
• Applicant Address: COOK MEDICAL INCORPORATED 750 Daniels Way p.o. Box 489 bloomington, IN 47402-0489

Supplemental Filings

Supplement Number	Date	Supplement Type
P100028		Original Filing
S004	2013-09-20	Normal 180 Day Track No User Fee
S003	2013-01-28	Normal 180 Day Track
S002	2012-02-13	Real-time Process
S001	2011-10-06	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
10827002569758	P100028	001
10827002569628	P100028	001
10827002569611	P100028	001
10827002569604	P100028	001
10827002569598	P100028	001
10827002569581	P100028	001
10827002185286	P100028	001
10827002185279	P100028	001
10827002185262	P100028	001
10827002185255	P100028	001
10827002185248	P100028	001
10827002569635	P100028	001
10827002569642	P100028	001
10827002569741	P100028	001
10827002569734	P100028	001
10827002569727	P100028	001
10827002569710	P100028	001
10827002569703	P100028	001
10827002569697	P100028	001
10827002569680	P100028	001
10827002569673	P100028	001
10827002569666	P100028	001
10827002569659	P100028	001
10827002185231	P100028	001