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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.
 
DeviceSEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake, IL 60015
PMA NumberP950034
Supplement NumberS001
Date Received10/22/1996
Decision Date11/07/1996
Product Code MCN 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE CURRENT HA/CMC SPECIFICATION FOR THE UREA ASSAY FROM THE CURRENT 3 - 15% TO A SPECIFICATION OF 10-18% FOR THE MODIFIED ASSAY. THE SUPPLEMENT ALSO REQUESTS THE REPLACEMENT OF THE USP RABBIT PYROGEN ASSAY WITH THE LIMULUS AMOEBOCYTE LYSATE (LAL) ASSAY AS THE STANDARD PYROGEN TEST
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