- Device
- Plasmaflo OP-05W (A)
- Applicant
- Asahi Kasei Medical Co., Ltd.
- PMA number
- P820033
- Supplement
- S015
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2022-02-08
- Decision code
- OK30
- Date received
- 2022-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of new equipment for the EVOH coating process, and the hollow fiber (HF) drying process to increase the hollow fiber drying capacity.