|
Device | LIFESTENT AND LIFESTENT XL 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 | S010 |
Date Received | 03/10/2010 |
Decision Date | 12/23/2010 |
Product Code |
NIP |
Docket Number | 11M-0039 |
Notice Date | 01/25/2011 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS. THE LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS ARE INTENDED TO IMPROVE LUMINAL DIAMETER IN THE TREATMENT OF SYMPTOMATIC DE-NOVO OR RESTENOTIC LESIONS UP TO 240 MM IN LENGTH IN NATIVE SUPERFICIAL FEMORAL ARTERY (SFA) AND/OR PROXIMAL POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS RANGING FROM 4.0 ¿ 6.5 MM. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |