PMA P830063S013
- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- Product code
- MDP
- Decision date
- 2021-02-12
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- Approval for a change in the parting line on the blood ports of the support plate of the manufacturing mold.
Current openFDA PMA Record#
- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S013
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2021-02-12
- Decision code
- APPR
- Date received
- 2019-09-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the parting line on the blood ports of the support plate of the manufacturing mold.