Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: LIFESTENT VASCULAR STENT SYSTEMS
• Generic Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Applicant: Bard Peripheral Vascular, Inc.; 1415 W. 3rd St.; Tempe, AZ 85281
• PMA Number: P070014
• Supplement Number: S014
• Date Received: 04/13/2010
• Decision Date: 10/18/2010
• Product Code: NIP
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Postapproval Study Protocol - OSB
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.