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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 Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
PMA NumberP850010
Supplement NumberS045
Date Received08/14/2013
Decision Date04/04/2014
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following proposed changes: 1) change in cleaning detergent from metrizyme (formulated enzymatic cleaner) to cip-100 (formulated alkaline cleaner); 2) establishment of an equipment dirty hold time (dht) of 24-hours; 3) utilization of 70% isopropyl alcohol (ipa), as required; 4) utilization of sodium lauryl sulfate (sls), as required; and 5) establishing the use of total organic carbons (tocs) as a method to test for residues.