PMA P950034S058
- Device
- Seprafilm Adhesion Barrier
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S058
- Product code
- MCN
- Decision date
- 2024-07-03
- Classification
- General, Plastic Surgery
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- addition of an alternate supplier of the raw material Sodium Hyaluronate
Current openFDA PMA Record#
- Device
- Seprafilm Adhesion Barrier
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S058
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2024-07-03
- Decision code
- OK30
- Date received
- 2024-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternate supplier of the raw material Sodium Hyaluronate