- Device
- Plasmaflo OP-05 W(A)
- Applicant
- Asahi Kasei Medical Co., Ltd.
- PMA number
- P820033
- Supplement
- S019
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2026-04-09
- Decision code
- OK30
- Date received
- 2026-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the acceptance criterion for the opening torque test performed during in-process inspection of the Plasmaflo™ OP-05W(A) filter