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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 Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
311 enterprise dr.
plainsboro, NJ 08540
PMA NumberP850010
Supplement NumberS033
Date Received05/01/2013
Decision Date11/29/2013
Product Code
LMF[ Registered Establishments with LMF ]
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.