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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHELISTAT(TM) ABSORBABLE COLLAGEN HEMOSTATIC SPONGE
Classification Nameagent, absorbable hemostatic, collagen based
Generic Nameabsorbable collagen hemostatic sponge
Regulation Number878.4490
ApplicantCOLLA-TEC, INC.
PMA NumberP850010
Date Received02/20/1985
Decision Date11/08/1985
Product Code
LMF[ Registered Establishments with LMF ]
Docket Number 85M-0557
Notice Date 01/02/1986
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S003 S004 S005 S006 S007 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S025 S026 S027 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 S055 S056 
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