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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.
 
DeviceINTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Generic NameDevice, dermal replacement
ApplicantIntegra Lifesciences Corp.
105 Morgan Ln.
Plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS026
Date Received04/26/2013
Decision Date02/05/2015
Product Codes MDD MGR 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE FOLLOWING CHANGES:1) CHANGE IN CLEANING DETERGENT FOR CERTAIN EQUIPMENT;2) CHANGE IN CLEANING METHOD FOR CERTAIN EQUIPMENT, UTILIZING ISOPROPYL ALCOHOL;3) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIME (DHT); AND 4) ESTABLISHMENT OF A METHOD TO TEST FOR RESIDUES.
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