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, CollaTape, and CollaPlug 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 | S077 |
Date Received | 10/19/2020 |
Decision Date | 11/18/2020 |
Product Code |
LPG |
Advisory Committee |
Dental |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Sampling site changes in Routine Environmental Monitoring for Alkaline treatment rooms at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey. |
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