PMA P950034S013

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S013
Product code: MCN
Decision date: 1999-09-03
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 a new Urania Heat Sealer, Model 3500-P, to seal the foil pouches containing Seprafilm(R).

Current openFDA PMA Record#

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S013
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 1999-09-03
Decision code: OK30
Date received: 1999-08-09
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 a new Urania Heat Sealer, Model 3500-P, to seal the foil pouches containing Seprafilm(R).