- Device
- Gambro Prismaflex TPE 2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S020
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2022-01-27
- Decision code
- APPR
- Date received
- 2021-11-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the polyvinyl chloride (PVC) material used for the production of the joint connectors in the Prismaflex TPE2000 Set.