|
Device | lntegraQ Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenera |
Generic Name | Dressing, wound and burn, interactive |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S061 |
Date Received | 03/31/2017 |
Decision Date | 04/24/2017 |
Product Code |
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 tissue grinder |