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SEPRAFILM BIORESORBABLE MEMBRANE

FDA premarket approval P950034/S020 · decided 2001-09-28

Approval details

PMA number
P950034
Supplement
S020
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
SEPRAFILM BIORESORBABLE MEMBRANE
Generic name
Barrier, absorbable, adhesion
Applicant
Baxter Healthcare Corporation
Date received
2001-08-29
Decision date
2001-09-28
Days to decision
30 days
Decision code
OK30
Product code
MCN
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Deerfield Lake, IL
Statement
CHANGE INVOLVING CONVERTING THE SEPRAFILM MANUFACTURING AREA FROM A DEDICATED AREA TO A SHARED AREA SHERE STERILE HYALURONIC ACID (HA) WILL BE PRODUCED. THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES WITH THE PROPER CLEANING OF THE THREE VESSELS. THE CLEANING PROCESS HAS BEEN VALIDATED.

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