|
Device | Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template, Integra Omnigraft Dermal Regeneration |
Generic Name | Dressing, wound and burn, interactive |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S059 |
Date Received | 12/19/2016 |
Decision Date | 01/17/2017 |
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 Modifications to the Water for Injection pretreatment, generation and distribution system. |