|
Device | FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM |
Generic Name | STENT, RENAL |
Applicant | COOK MEDICAL INCORPORATED 750 DANIELS WAY P.O. BOX 489 BLOOMINGTON, IN 47402-0489 |
PMA Number | P100028 |
Supplement Number | S003 |
Date Received | 01/28/2013 |
Decision Date | 03/28/2014 |
Product Code |
NIN |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00631540
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ADDITIONAL DELIVERY SYSTEM (FORMULA 535 DELIVERY SYSTEM) FOR THE FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM. |
Post-Approval Study | Show Report Schedule and Study Progress |