- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S027
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2024-01-10
- Decision code
- OK30
- Date received
- 2023-12-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the transfer of manufacturing site for components of the Prismaflex TPE2000 Set and a manufacturing process change for the removal of a superfluous air flow test ofthe Prismaflex TPE2000 Set