GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N
FDA premarket approval P830063/S002 · decided 2002-08-28
Approval details
- PMA number
- P830063
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2000-01-18
- Decision date
- 2002-08-28
- Days to decision
- 953 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- APPROVAL FOR MODIFICATIONS TO THE REQUIREMENTS OF THE POST-MARKET STUDY FOR THE DEVICE.
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