PMA P820033S012
- Device
- Plasmaflo OP-05W(A)
- Applicant
- Asahi Kasei Medical Co., Ltd.
- PMA number
- P820033
- Supplement
- S012
- Product code
- MDP
- Decision date
- 2018-02-15
- Classification
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- Change in the bioburden recovery procedure for the Plasmaflo OP-05W(A).
Current openFDA PMA Record#
- Device
- Plasmaflo OP-05W(A)
- Applicant
- Asahi Kasei Medical Co., Ltd.
- PMA number
- P820033
- Supplement
- S012
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2018-02-15
- Decision code
- OK30
- Date received
- 2018-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the bioburden recovery procedure for the Plasmaflo OP-05W(A).