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: XACT CAROTID STENT SYSTEM
• Classification Name: stent, carotid
• Generic Name: carotid stent system
• Applicant: ABBOTT VASCULAR DEVICES
• PMA Number: P040038
• Supplement Number: S001
• Date Received: 09/29/2005
• Decision Date: 10/12/2005
• 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.