PMA P830063S012
- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S012
- Product code
- MDP
- Decision date
- 2019-09-18
- Classification
- Separator For Therapeutic Purposes, Membrane Automated Blood Cell/plasma
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- Approval for the use of the Prismaflex TPE2000 Set with the PrisMax Control Unit (Version 2) and modifications to the Instructions for Use.
Current openFDA PMA Record#
- Device
- Prismaflex TPE2000 Set
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S012
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2019-09-18
- Decision code
- APPR
- Date received
- 2019-06-27
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the use of the Prismaflex TPE2000 Set with the PrisMax Control Unit (Version 2) and modifications to the Instructions for Use.