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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, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings for Dental Surgery
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantIntegra Lifesciences Corp.
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP840062
Supplement NumberS076
Date Received05/28/2019
Decision Date06/27/2019
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  
Equipment modifications and introduction of a one-piece flow methodology within the Cutting, Inspection and Packaging room within the Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, New Jersey.
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