|
Device | INTEGRA DERMAL REGENERATION TEMPLATE |
Generic Name | Dressing, wound and burn, interactive |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S063 |
Date Received | 06/29/2017 |
Decision Date | 09/08/2017 |
Product Code |
MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Steris Applied Sterilization Technologies (AST) Electron Beam (E-Beam) processing facility located at 7225 North Noah Drive, Saxonburg, Pennsylvania, 16056, as an alternate E-Beam Sterilization facility for the Integra Regeneration Template (IDRT) product family. |