PRISMAFLEX TPE 2000 Set
FDA premarket approval P830063/S016 · decided 2020-05-23
Approval details
- PMA number
- P830063
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRISMAFLEX TPE 2000 Set
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2020-03-05
- Decision date
- 2020-05-23
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- Approval for a minor change to the raw material used for the header cap component, which is part of the plasmafilter subassembly of the PRISMAFLEX TPE2000 Set.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |