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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(TM)
Generic NameMATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
ApplicantIntegra Lifesciences Corp.
311 Enterprise Dr.
Planisboro, NJ 08536
PMA NumberP840062
Supplement NumberS060
Date Received01/17/2017
Decision Date02/16/2017
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  
Various installation, operation and environmental monitoring of anti-static bars, stainless steel shroud, vacuum port, and particle trap in the Integra Packaging Room.
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