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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.
 
DeviceCollastat/INSTAT Absorbable Collagen Hemostatic Agent
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP810006
Supplement NumberS102
Date Received01/27/2023
Decision Date02/23/2023
Product Code LMF 
Advisory Committee General & Plastic Surgery
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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