SEPRAFILM BIORESORBABLE MEMBRANE
FDA premarket approval P950034/S012 · decided 1999-08-27
Approval details
- PMA number
- P950034
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SEPRAFILM BIORESORBABLE MEMBRANE
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 1999-08-03
- Decision date
- 1999-08-27
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- The 30-Day Notice requested a manufacturing process change for Seprafilm(R) Bioresorbable Membrane. The requested change would allow the use of LabelMax software and high speed laser printers to print the entire Seprafilm(R) Pouch Front Label and a new 10 Pack Box/Envelop Carton Label.
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