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Device | INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED |
Generic Name | Device, dermal replacement |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S054 |
Date Received | 11/24/2015 |
Decision Date | 05/03/2016 |
Product Codes |
MDD 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 a manufacturing site located at Integra LifeSciences Corporation, 109 Morgan Lane, Plainsboro, New Jersey, as a new and alternate manufacturing facility. |