PMA P950034
- Device
- Seprafilm Adhesion Barrier
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S055
- Product code
- MCN
- Decision date
- 2024-12-19
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- to request approval to eliminate a redundant in-process weight check in the production of the Seprafilm Adhesion Barrier (‘Seprafilm’) device
Current openFDA PMA Record#
- Device
- Seprafilm Adhesion Barrier
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S059
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2024-12-19
- Decision code
- OK30
- Date received
- 2024-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to request approval to eliminate a redundant in-process weight check in the production of the Seprafilm Adhesion Barrier (‘Seprafilm’) device