|
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 | S032 |
Date Received | 11/01/2013 |
Decision Date | 03/18/2014 |
Product Codes |
MDD MGR |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR ADDING INCREASED SYSTEM CAPACITY FOR WATER PURIFICATION OF THE CURRENT REVERSE OSMOSIS/ELECTRO-DEIONIZATION WATER PURIFICATION SYSTEM (ROEDI). |