PMA P950034S056
- Device
- Seprafilm Adhesion Barrier
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S056
- Product code
- MCN
- Decision date
- 2023-11-02
- Classification
- General, Plastic Surgery
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- approval to add new information to the Warnings Section of the Seprafilm Adhesion Barrier ('Seprafilm') Instructions for Use.
Current openFDA PMA Record#
- Device
- Seprafilm Adhesion Barrier
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S056
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2023-11-02
- Decision code
- APPR
- Date received
- 2023-10-05
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval to add new information to the Warnings Section of the Seprafilm Adhesion Barrier ('Seprafilm') Instructions for Use.