PMA P950034S057
- Device
- Seprafilm Adhesion Barrier
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S057
- Product code
- MCN
- Decision date
- 2024-01-02
- Classification
- General, Plastic Surgery
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- change in lowering the endotoxin limit in the final release specifications
Current openFDA PMA Record#
- Device
- Seprafilm Adhesion Barrier
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S057
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2024-01-02
- Decision code
- OK30
- Date received
- 2023-12-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- change in lowering the endotoxin limit in the final release specifications