PMA P950034S020

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S020
Product code: MCN
Decision date: 2001-09-28
Generic name: Barrier, absorbable, adhesion
Approval order 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.

Current openFDA PMA Record#

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S020
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2001-09-28
Decision code: OK30
Date received: 2001-08-29
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.