- Device
- Plasmaflo OP-05W(A)
- Applicant
- Asahi Kasei Medical Co., Ltd.
- PMA number
- P820033
- Supplement
- S014
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2021-03-03
- Decision code
- OK30
- Date received
- 2021-02-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the sterilization test method performed at the 3-month sterilization dose audit for the Plasmaflo OP-05W(A).