Atlas FDA

SEPRAFILM(TM) BIORESORBABLE MEMBRANE

FDA premarket approval P950034/S015 · decided 2000-06-23

Approval details

PMA number
P950034
Supplement
S015
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
SEPRAFILM(TM) BIORESORBABLE MEMBRANE
Generic name
Barrier, absorbable, adhesion
Applicant
Baxter Healthcare Corporation
Date received
2000-05-24
Decision date
2000-06-23
Days to decision
30 days
Decision code
OK30
Product code
MCN
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Deerfield Lake, IL
Statement
THE ELIMINATION OF ANNUAL LOT STABILITY TESTING FOR SEPRAFILM(TM) BIORESORBABLE MEMBRANE (SEPRAFILM(TM)). THIS CHANGE WILL ELIMINATE THE ANNUAL LOT STABILITY TESTING REQUIREMENT, AND DECREASE THE QUANTITY OF THE PRODUCT USED FOR STABILITY LOT FAILURES DURING A TESTING PERIOD OF OVER THREE YEARS.

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