PMA P950034S010

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S010
Product code: MCN
Decision date: 1999-01-13
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 processed ethanol to be reused during the precipitation step of the sodium hyaluronate/carboxymethylecellulose (HA/CMC) powder manufacturing process.

Current openFDA PMA Record#

Device: SEPRAFILM BIORESORBABLE MEMBRANE
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S010
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 1999-01-13
Decision code: OK30
Date received: 1998-12-22
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 processed ethanol to be reused during the precipitation step of the sodium hyaluronate/carboxymethylecellulose (HA/CMC) powder manufacturing process.