PMA P820033S017

Device: Plasmaflo OP-05W(A)
Applicant: Asahi Kasei Medical Co., Ltd.
PMA number: P820033
Supplement: S017
Product code: MDP
Decision date: 2025-09-30
Classification: Gastroenterology, Urology
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Approval order statement: Your supplement requested approval for a change in the supplier of the lubricant, calcium stearate, added to the polyethylene resin used in the manufacture of the hollow fiber of the device.

Current openFDA PMA Record#

Device: Plasmaflo OP-05W(A)
Applicant: Asahi Kasei Medical Co., Ltd.
PMA number: P820033
Supplement: S017
Product code: MDP
Generic name: Separator for therapeutic purposes, membrane automated blood cell/plasma
Decision date: 2025-09-30
Decision code: APPR
Date received: 2024-02-06
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Your supplement requested approval for a change in the supplier of the lubricant, calcium stearate, added to the polyethylene resin used in the manufacture of the hollow fiber of the device.