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: SEPRAFILM
• Classification Name: barrier, absorable, adhesion
• Generic Name: barrier, absorbalble, adhesion
• Applicant: GENZYME CORP.
• PMA Number: P950034
• Supplement Number: S033
• Date Received: 08/16/2010
• Decision Date: 09/14/2010
• Product Code: MCN [ Registered Establishments with MCN ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of a new procedure for the seprafilm labeling and packaging.