PMA P950034S044

Device: SEPRAFILM ADHESION BARRIER
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S044
Product code: MCN
Decision date: 2016-01-07
Generic name: Barrier, absorbable, adhesion
Approval order statement: ADDITIONAL SUPPLIER OF POLY(METHYL METHACRYLATE) (PMMA), PLASKOLITE, TO BE QUALIFIED FOR USE IN THE MANUFACTURE OF THE CASTING SHEETS PRODUCED BY AIN PLASTICS. THE CASTING SHEETS ARE IN TURN USED IN THE MANUFACTURE OF THE DEVICE (SEPRAFILM).

Current openFDA PMA Record#

Device: SEPRAFILM ADHESION BARRIER
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S044
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2016-01-07
Decision code: OK30
Date received: 2015-12-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ADDITIONAL SUPPLIER OF POLY(METHYL METHACRYLATE) (PMMA), PLASKOLITE, TO BE QUALIFIED FOR USE IN THE MANUFACTURE OF THE CASTING SHEETS PRODUCED BY AIN PLASTICS. THE CASTING SHEETS ARE IN TURN USED IN THE MANUFACTURE OF THE DEVICE (SEPRAFILM).