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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.
 
DeviceHELISTAT ABSORABABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameagent, absorbable hemostatic, collagen based
Regulation Number878.4490
Applicant
COLLA-TEC, INC.
105 morgan ln.
plainsboro, NJ 08536
PMA NumberP850010
Supplement NumberS044
Date Received08/14/2013
Decision Date04/08/2014
Product Code
LMF[ Registered Establishments with LMF ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following proposed changes: 1) cleaning validation for the microfibrillar grinding process equipment; 2) establishment of dirty hold time;3) total organic carbon (toc) recovery study for swab and rinse on stainless steel surfaces; and4) toc recovery study for swab and rinse on teflon surfaces.
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