GAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N
FDA premarket approval P830063/S004 · decided 2002-05-10
Approval details
- PMA number
- P830063
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GAMBRO PRISM TPE 2000 SET WITH PLASMAFILTER PF2000N
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2001-11-13
- Decision date
- 2002-05-10
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- 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.
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