SEPRAFILM ADHESION BARRIER
FDA premarket approval P950034/S021 · decided 2002-03-26
Approval details
- PMA number
- P950034
- Supplement
- S021
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SEPRAFILM ADHESION BARRIER
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2002-03-01
- Decision date
- 2002-03-26
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- 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.
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