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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™ Absorbable Collagen Hemostatic Sponge and Collastat™ Absorbable Collagen Hemostatic Agent - Microfibrillar Fo
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantIntegra LifeSciences Corporation
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP810006
Supplement NumberS101
Date Received11/21/2022
Decision Date12/19/2022
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  
For the Environmental Monitoring Process Qualification of Room 307, at the Collagen Manufacturing Center (CMC) located at 105 Morgan Lane, Plainsboro, NJ 08536.
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