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: INTEGRA DERMAL REGENERATION TEMPLATE
• Classification Name: dressing, wound and burn, interactive
• Generic Name: artificial skin burn wound covering
• Applicant: INTEGRA
• PMA Number: P900033
• Supplement Number: S022
• Date Received: 07/23/2012
• Decision Date: 08/22/2012
• Product Code: MGR [ Registered Establishments with MGR ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Changes to the cleaning processes associated with the production equipment.