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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®, and 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 NumberS085
Date Received04/20/2022
Decision Date05/20/2022
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 two (2) modules of the water purification (RODEI) system with four (4) like-in-kind modules from the same manufacturer to increase purified water capacity at the Integra NeuroSciences manufacturing facility located at Road 402 North, Km 1.2 Añasco, PR 00610.
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