PMA P830063S006
- Device
- PRISMAFLEX TPE 2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S006
- Product code
- MDP
- Decision date
- 2011-06-17
- 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 MODIFICATIONS TO THE GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF 2000N TO PERMIT THE USE OF THE PLASMAFILTER WITH THE GAMBRO PRISMAFLEX SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISMAFLEX TPE 2000 SET AND IS INDICATED FOR THERAPEUTIC PLASMAPHERESIS.
Current openFDA PMA Record#
- Device
- PRISMAFLEX TPE 2000 SET
- Applicant
- Vantive US Healthcare, LLC
- PMA number
- P830063
- Supplement
- S006
- Product code
- MDP
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Decision date
- 2011-06-17
- Decision code
- APPR
- Date received
- 2007-10-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF 2000N TO PERMIT THE USE OF THE PLASMAFILTER WITH THE GAMBRO PRISMAFLEX SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PRISMAFLEX TPE 2000 SET AND IS INDICATED FOR THERAPEUTIC PLASMAPHERESIS.