PRISMAFLEX TPE 2000 SET
FDA premarket approval P830063/S006 · decided 2011-06-17
Approval details
- PMA number
- P830063
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRISMAFLEX TPE 2000 SET
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2007-10-09
- Decision date
- 2011-06-17
- Days to decision
- 1347 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- 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.
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