|
Device | INTEGRA ARTIFICIAL SKIN |
Generic Name | Dressing, wound and burn, interactive |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S003 |
Date Received | 11/08/1999 |
Decision Date | 11/23/1999 |
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 The 30-Day Notice requested a change to the Quality Control test used to determine the chondroitin-6-sulfate content in INTEGRA(R) Artificial Skin, Dermal Regeneration Template. |