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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.
 
DeviceHEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR
Generic NameAgent, absorbable hemostatic, collagen based
Regulation Number878.4490
ApplicantDatascope Corp.
45 Barbour Pond Dr.
Wayne, NJ 07470
PMA NumberP850023
Supplement NumberS011
Date Received07/26/1991
Decision Date10/04/1991
Withdrawal Date02/28/2025
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
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