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: DERMABOND TOPICAL SKIN ADHESIVE
• Classification Name: tissue adhesive for the topical approximation of skin
• Generic Name: topical tissue adhesive
• Regulation Number: 878.4010
• Applicant: CLOSURE MEDICAL CORP.
• PMA Number: P960052
• Supplement Number: S012
• Date Received: 08/16/2006
• Decision Date: 09/14/2006
• Product Code: MPN [ Registered Establishments with MPN ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change to the sterilization process.