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SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE

FDA premarket approval P950034/S001 · decided 1996-11-07

Approval details

PMA number
P950034
Supplement
S001
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
Generic name
Barrier, absorbable, adhesion
Applicant
Baxter Healthcare Corporation
Date received
1996-10-22
Decision date
1996-11-07
Days to decision
16 days
Decision code
APPR
Product code
MCN
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Deerfield Lake, IL
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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