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Device | COLLAPLUG 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 | S019 |
Date Received | 03/09/2009 |
Decision Date | 06/09/2009 |
Product Code |
LPG |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ADDITIONAL TRADE NAME, ORAPLUG, TO THE COLLAPLUG ABSORBABLE COLLAGEN WOUND DRESSING. |