PMA P950034S021

Device: SEPRAFILM ADHESION BARRIER
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S021
Product code: MCN
Decision date: 2002-03-26
Classification: Barrier, Absorbable, Adhesion
Generic name: Barrier, absorbable, adhesion
Approval order statement: MANUFACTURING CHANGE TO REPLACE THE CURRENT MANUAL CLEANING PROCESS FOR REMOVING RESIDUAL MANUFACTURING MATERIALS FROM EQUIPMENT WITH A SEMI-AUTOMATIC SUBSTRATE WASHER. THE SEMI-AUTOMATIC SUBSTRATE WASHER WOULD DECREASE THE TIME AND LABOR USED IN THE MANUFACTURING CLEANING PROCESS.

Current openFDA PMA Record#

Device: SEPRAFILM ADHESION BARRIER
Applicant: Baxter Healthcare Corporation
PMA number: P950034
Supplement: S021
Product code: MCN
Generic name: Barrier, absorbable, adhesion
Decision date: 2002-03-26
Decision code: OK30
Date received: 2002-03-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MANUFACTURING CHANGE TO REPLACE THE CURRENT MANUAL CLEANING PROCESS FOR REMOVING RESIDUAL MANUFACTURING MATERIALS FROM EQUIPMENT WITH A SEMI-AUTOMATIC SUBSTRATE WASHER. THE SEMI-AUTOMATIC SUBSTRATE WASHER WOULD DECREASE THE TIME AND LABOR USED IN THE MANUFACTURING CLEANING PROCESS.