Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: LIFESTENT VASCULAR STENT SYSTEM
• Classification Name: stent, superficial femoral artery
• Generic Name: peripheral(sfa) stent system
• Applicant: BARD PERIPHERAL VASCULAR, INC.
• PMA Number: P070014
• Supplement Number: S033
• Date Received: 08/15/2012
• Decision Date: 09/12/2012
• Product Code: NIP [ Registered Establishments with NIP ]
• Advisory Committee: Cardiovascular
• Supplement Type: Special Supplement
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the separation of the manufacturing and inspection responsibilities for the manual press process.