|
Device | COLLACOTE ABSORBABLE COLLAGEN WOUND DRESSING |
Generic Name | MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID |
Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P840062 |
Supplement Number | S018 |
Date Received | 02/02/2009 |
Decision Date | 03/26/2009 |
Product Code |
LPG |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES. |