PMA P950034S012

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S012
Product code: MCN
Decision date: 1999-08-27
Generic name: Barrier, absorbable, adhesion
Approval order statement: The 30-Day Notice requested a manufacturing process change for Seprafilm(R) Bioresorbable Membrane. The requested change would allow the use of LabelMax software and high speed laser printers to print the entire Seprafilm(R) Pouch Front Label and a new 10 Pack Box/Envelop Carton Label.

Current openFDA PMA Record#

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S012
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 1999-08-27
Decision code: OK30
Date received: 1999-08-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-Day Notice requested a manufacturing process change for Seprafilm(R) Bioresorbable Membrane. The requested change would allow the use of LabelMax software and high speed laser printers to print the entire Seprafilm(R) Pouch Front Label and a new 10 Pack Box/Envelop Carton Label.