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: DURASEAL XACT SPINE SEALANT SYSTEM
• Classification Name: sealant, dural
• Applicant: COVIDIEN
• PMA Number: P080013
• Supplement Number: S006
• Date Received: 03/21/2011
• Decision Date: 05/20/2011
• Product Code: NQR [ Registered Establishments with NQR ]
• Advisory Committee: Neurology
• 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.