|
Device | INTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE |
Generic Name | Device, dermal replacement |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S037 |
Date Received | 06/23/2014 |
Decision Date | 07/03/2014 |
Product Codes |
MDD MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE CLEANING VALIDATION TO EXTEND THE DIRTY HOLD TIME OF TANKS TK-01 AND TK-02 USED IN THE WET PROCESSING FORMULATION. |