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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 ABSORBABLE COLLAGEN 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
Supplement NumberS014
Date Received08/25/2003
Decision Date09/26/2003
Withdrawal Date 10/18/2021
Product Code LMF 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE "INDICATIONS FOR USE" STATEMENT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME INSTAT ABSORBABLE COLLAGEN HEMOSTAT AND IS INDICATED FOR USE "IN SURGICAL PROCEDURES (OTHER THAN IN OPHTHALMOLOGICAL SURGERY) AS AN ADJUNCT TO HEMOSTASIS WHEN CONTROL OF BLEEDING BY LIGATURE OR OTHER CONVENTIONAL PROCEDURES IN INEFFECTIVE OR IMPRACTICAL. INSTAT HEMOSTAT CAN BE CUT TO SIZE FOR USE IN ENDOSCOPIC PROCEDURES."
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