|
Device | Bard LifeStent 5F Vascular Stent System |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P070014 |
Supplement Number | S055 |
Date Received | 06/01/2018 |
Decision Date | 08/01/2018 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a labeling change to add 0.014” guidewires for use with the LifeStent 5F Vascular Stent System. |