PMA P830063S001
- Device
- GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S001
- Product code
- MDP
- Decision date
- 1996-08-28
- 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 A CHANGE OF MATERIAL USED IN THE HOUSING OF THE DEVICE, END CAP CONFIGURAITON MODIFICATION AND SPECIFICATION CHAGNES TO THE DEVICE MEMBRANE (I.E., DECREASE IN NUMBER OF HOLLOW FIBERS AND INCREASE IN HOLLOW FIBER LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER AND IS INDICATED FOR USE IN THERAPEUTIC PLASMAFILTRATION IN DISEASES WHERE REMOVAL OF PLASMA COMPONENTS ARE INDICTED, INCLUDING PLASMAFILTRATION PROCEDURESWHERE FILTERED PLASMA IS REINFUSED
Current openFDA PMA Record#
- Device
- GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S001
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 1996-08-28
- Decision code
- APPR
- Date received
- 1995-07-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE OF MATERIAL USED IN THE HOUSING OF THE DEVICE, END CAP CONFIGURAITON MODIFICATION AND SPECIFICATION CHAGNES TO THE DEVICE MEMBRANE (I.E., DECREASE IN NUMBER OF HOLLOW FIBERS AND INCREASE IN HOLLOW FIBER LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER AND IS INDICATED FOR USE IN THERAPEUTIC PLASMAFILTRATION IN DISEASES WHERE REMOVAL OF PLASMA COMPONENTS ARE INDICTED, INCLUDING PLASMAFILTRATION PROCEDURESWHERE FILTERED PLASMA IS REINFUSED