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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceCollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantIntegra Lifesciences Corp.
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP840062
Supplement NumberS087
Date Received01/27/2023
Decision Date02/23/2023
Product Code LPG 
Advisory Committee Dental
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Replacement of the current stainless-steel AT basket/paddle with a modular polyethylene/stainless steel AT basket to improve ergonomics and reduce wear particles as a result of paddle motion at the Integra LifeSciences Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, NJ 08536.
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