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 SYSTEMS
• Classification Name: stent, carotid
• Applicant: EV3 INC
• PMA Number: P060001
• Supplement Number: S011
• Date Received: 02/16/2011
• Decision Date: 03/08/2011
• Product Code: NIM [ Registered Establishments with NIM ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study protocol.