PMA P830063S004
- Device
- GAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S004
- Product code
- MDP
- Decision date
- 2002-05-10
- 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 PERMANENT BONDING OF TUBING LINES ONTO THE PLASMAFILTER PF2000N. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISM TPE 2000 SET, AND IS INDICATED FOR USE IN PERFORMING THERAPEUTIC PLASMA SEPARATION FROM WHOLE BLOOD IN A CLINICAL SETTING TO REMOVE CIRCULATING PLASMA COMPONENTS OR PROTEIN BOUND TOXINS.
Current openFDA PMA Record#
- Device
- GAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S004
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2002-05-10
- Decision code
- APPR
- Date received
- 2001-11-13
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE PERMANENT BONDING OF TUBING LINES ONTO THE PLASMAFILTER PF2000N. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISM TPE 2000 SET, AND IS INDICATED FOR USE IN PERFORMING THERAPEUTIC PLASMA SEPARATION FROM WHOLE BLOOD IN A CLINICAL SETTING TO REMOVE CIRCULATING PLASMA COMPONENTS OR PROTEIN BOUND TOXINS.