PMA P950034S052
- Device
- SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S052
- Product code
- MCN
- Decision date
- 2021-04-01
- Generic name
- Barrier, absorbable, adhesion
- Approval order statement
- Change to the clean hold time of a vessel used in the manufacturing process of Seprafilm Adhesion Barrier.
Current openFDA PMA Record#
- Device
- SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P950034
- Supplement
- S052
- Product code
- MCN
- Generic name
- Barrier, absorbable, adhesion
- Decision date
- 2021-04-01
- Decision code
- OK30
- Date received
- 2021-03-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the clean hold time of a vessel used in the manufacturing process of Seprafilm Adhesion Barrier.