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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceINSTAT(TM) COLLAGEN ABSORBABLE HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantETHICON, INC.
ROUTE 22 WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151
PMA NumberP830079
Date Received12/23/1983
Decision Date10/10/1985
Withdrawal Date 10/18/2021
Product Code LMF 
Docket Number 85M-0507
Notice Date 11/15/1985
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements:  S001 S002 S003 S006 S007 S008 S009 S010 S011 S012 S014 
S015 S016 S017 
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