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: PROTEGE GPS & PROTEGE RX CAROTID STENT SYSTEM
• Classification Name: stent, carotid
• Applicant: EV3 INC
• PMA Number: P060001
• Supplement Number: S004
• Date Received: 12/31/2007
• Decision Date: 01/30/2008
• Product Code: NIM [ Registered Establishments with NIM ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Use of an alternate sterilization chamber for the above listed products.