Seprafilm Adhesion Barrier
FDA premarket approval P950034/S056 · decided 2023-11-02
Approval details
- PMA number
- P950034
- Supplement
- S056
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Seprafilm Adhesion Barrier
- Generic name
- Barrier, absorbable, adhesion
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2023-10-05
- Decision date
- 2023-11-02
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- MCN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- approval to add new information to the Warnings Section of the Seprafilm Adhesion Barrier ('Seprafilm') Instructions for Use.
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