|
Device | LIFESTENT VASCULAR STENT SYSTEMS |
Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
Applicant | BARD PERIPHERAL VASCULAR, INC. 1415 WEST 3RD ST. TEMPE, AZ 85281 |
PMA Number | P070014 |
Supplement Number | S018 |
Date Received | 09/09/2010 |
Decision Date | 10/14/2010 |
Product Code |
NIP |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00673985
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN LABELING THAT UPDATES THE INSTRUCTIONS FOR USE AND THE PATIENT INFORMATION BROCHURE TO INCLUDE THE MOST RECENT CLINICAL DATA UP TO 3 YEARS. |