|
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 | S043 |
Date Received | 02/03/2015 |
Decision Date | 03/04/2015 |
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 QUALIFICATION OF A NEW PRODUCT PACKAGE SEALING EQUIPMENT FOR THE INTEGRA DERMAL REGENERATION TEMPLATE, AT THE PLAINSBORO, NEW JERSEY, INTEGRA MANUFACTURING FACILITY. |