Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | COLLACOTE(R),COLLATAPE(R),COLLAPLUG(R), DRESSINGS |
Generic Name | MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID |
Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P840062 |
Supplement Number | S006 |
Date Received | 07/25/1995 |
Decision Date | 09/08/1995 |
Product Code |
LPG |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY FOR COLLACOTE, COLLATAPE AND COLLAPLUG DRESSINGS AT FRIFFITH MICROSCIENCE, INC., 27 PARK ROAD, GLEN FALLS, NY 12801 |
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