GAMBRO PLASMAFILTER, PF2000N
FDA premarket approval P830063/S003 · decided 2000-11-20
Approval details
- PMA number
- P830063
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GAMBRO PLASMAFILTER, PF2000N
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 2000-10-31
- Decision date
- 2000-11-20
- Days to decision
- 20 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- APPROVAL TO 1) EXPAND THE INSTRUCTIONS FOR USE (IFUS) TO PERMIT THE BLOOD FLOW DIRECTION DURING USE TO BE OPPOSITE TO THE DIRECTION OF FLOW OF THE RINSING AND PRIMING SOLUTIONS, AND TO 2) REMOVE THE BLOOD FLOW DIRECTION ARROW FROM THE DEVICE LABEL.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |