- Device
- SEPRAFILM BIORESORBABLE MEMBRANE
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S014
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2000-03-23
- Decision code
- APPR
- Date received
- 2000-02-18
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the use of Denatured Alcohol 3C to precipitate the sodium hyaluronate/carboxymethylcellulose powder (HA/CMC) rather than ethyl alcohol.