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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.
Classification Namedevice, dermal replacement
Generic Namedevice, dermal replacement
Integra LifeSciences Corp.
105 morgan ln.
plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS027
Date Received05/01/2013
Decision Date11/29/2013
Product Code
MDD[ Registered Establishments with MDD ]
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 Product No
Approval Order Statement 
Approval for the following proposed changes: 1) change in cleaning detergents; 2) establishment of equipment dirty hold times (dht); and 3) proposed use of total organic carbons (tocs) as a method to test for residues.