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Device | HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY |
Generic Name | MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID |
Applicant | INTEGRA LIFESCIENCES CORP. 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P840062 |
Supplement Number | S007 |
Date Received | 08/18/2000 |
Decision Date | 12/07/2000 |
Product Code |
LPG |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track |
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 FOR COLLACOTE, COLLATAPE AND COLLAPLUG. THESE DEVICES WILL ALSO BE KNOWN AS HELICOTE ABSORBABLE COLLAGEN WOUND DRESSINGS FOR DENTAL SURGERY. THE SIZES OF THE WOUND DRESSINGS WILL BE IDENTICAL TO THE THREE COLLACOTE PRODUCTS. THERE WILL BE NO CHANGES IN THE DEVICE EXCEPT THE USE OF AN ADDITIONAL NEW TRADE MANE. |