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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceINTEGRA ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Classification Namedevice, dermal replacement
Generic Namedevice, dermal replacement
Applicant
Integra LifeSciences Corp.
105 morgan ln.
plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS031
Date Received07/31/2013
Decision Date08/29/2013
Product Code
MDD[ Registered Establishments with MDD ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increase in the sample size for bacterial endotoxin testing (bet) for all collagen products manufactured at the plainsboro new jersey facility and at the anasco, puerto rico location.
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