PMA P820033S018
- Device
- Plasmaflo™ OP-05W(A)
- Applicant
- Asahi Kasei Medical Co., Ltd.
- PMA number
- P820033
- Supplement
- S018
- Product code
- MDP
- Decision date
- 2024-06-18
- Classification
- Gastroenterology, Urology
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- a change in the analytical device for endotoxin testing of Plasmaflo™ OP-05W(A)
Current openFDA PMA Record#
- Device
- Plasmaflo™ OP-05W(A)
- Applicant
- Asahi Kasei Medical Co., Ltd.
- PMA number
- P820033
- Supplement
- S018
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2024-06-18
- Decision code
- OK30
- Date received
- 2024-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the analytical device for endotoxin testing of Plasmaflo™ OP-05W(A)