|
Device | INTEGRA DERMAL REGENERATION TEMPLATE |
Generic Name | Device, dermal replacement |
Applicant | Integra LifeSciences Corp. 105 MORGAN LN. PLAINSBORO, NJ 08536 |
PMA Number | P900033 |
Supplement Number | S046 |
Date Received | 03/23/2015 |
Decision Date | 04/22/2015 |
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 PROPOSED QUALIFICATION OF THE LYO TRAY HANDLING CONVEYOR SYSTEM LOCATED AT THE INTEGRA NEUROSCIENCES, AÑASCO, PUERTO RICO FACILITY, FOR THE DEVICES. |