|
Device | INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS) |
Generic Name | Device, dermal replacement |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S021 |
Date Received | 10/13/2011 |
Decision Date | 05/24/2012 |
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 SYNERGY HEALTH AST, LLC IN DENVER, COLORADO. |