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: SEPRAFLIM ADHESION BARRIER
• Classification Name: barrier, absorable, adhesion
• Generic Name: barrier, absorbalble, adhesion
• Applicant: GENZYME CORP.
• PMA Number: P950034
• Supplement Number: S026
• Date Received: 08/05/2003
• Decision Date: 09/29/2003
• Product Code: MCN [ Registered Establishments with MCN ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: real-time process
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the seprafilm labeling.