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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINSTAT COLLAGEN ABSORBABLE HEMOSTAT
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantETHICON, Inc.
Rte. 22 W. P.O. Box 151
Somerville, NJ 08876
PMA NumberP830079
Supplement NumberS011
Date Received06/13/1995
Decision Date07/07/1995
Withdrawal Date10/18/2021
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO MARKET INSTAT COLLAGEN ABSORABLE HEMOSTAT (ALL SIZES) FOR ENDOSCOPIC PROCEDURES
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