PMA P830063
- Device
- PRISMAFLEX TPE2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S024
- Product code
- MDP
- Decision date
- 2026-07-15
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Approval order statement
- undefined
Current openFDA PMA Record#
- Device
- PRISMAFLEX TPE2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S032
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2026-07-15
- Decision code
- OK30
- Date received
- 2026-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- undefined