PMA P830063S005
- Device
- PRISMA TPE 2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S005
- Product code
- MDP
- Decision date
- 2009-06-19
- 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 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.
Current openFDA PMA Record#
- Device
- PRISMA TPE 2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S005
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2009-06-19
- Decision code
- APPR
- Date received
- 2006-11-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.