PRISMA TPE 2000 SET
FDA premarket approval P830063/S005 · decided 2009-06-19
Approval details
- PMA number
- P830063
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRISMA TPE 2000 SET
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2006-11-24
- Decision date
- 2009-06-19
- Days to decision
- 938 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE PRISMA TPE 2000 SET: 1) DIRECT CONNECTION OF THE PLASMAFILTER TO THE CARTRIDGE PLATE VIA THE DIALYSATE CONNECTORS; 2) OPTIMIZATION AND SIMPLIFICATION OF THE TUBING CIRCUIT; 3) THE PLASMAFILTER ORIENTED PARALLEL TO THE CARTRIDGE PLATE; 4) THE LINES FIXED BY PAWL AND RATCHET MECHANISM; 5) THE PUMP SEGMENT FIXED BY CLICKING VIA A SPECIFIC JOINT CONNECTOR; AND 6) BLOOD LINES SCREWED BY CONNECTORS TO THE BLOOD PORT FILTER.
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| Record | Firm | Date |
|---|---|---|
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |