|
Device | BARD LIFESTENT VASCULAR STENT |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P070014 |
Supplement Number | S046 |
Date Received | 05/20/2014 |
Decision Date | 06/17/2014 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement OPTIONAL PROCESS FOR TRANSFERRING A STENT TO A NEW DELIVERY SYSTEM CATHETER. |
Post-Approval Study | Show Report Schedule and Study Progress |