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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.
 
Trade NameHELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable hemostatic agents, collagen based
Regulation Number878.4490
ApplicantINTEGRA LIFESCIENCES CORPORATION
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.
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