GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER
FDA premarket approval P830063/S001 · decided 1996-08-28
Approval details
- PMA number
- P830063
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER
- Generic name
- Separator for therapeutic purposes, membrane automated blood cell/plasma
- Applicant
- Vantive US Healthcare, LLC
- Date received
- 1995-07-06
- Decision date
- 1996-08-28
- Days to decision
- 419 days
- Decision code
- APPR
- Product code
- MDP
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Deerfield, IL
- Statement
- APPROVAL FOR A CHANGE OF MATERIAL USED IN THE HOUSING OF THE DEVICE, END CAP CONFIGURAITON MODIFICATION AND SPECIFICATION CHAGNES TO THE DEVICE MEMBRANE (I.E., DECREASE IN NUMBER OF HOLLOW FIBERS AND INCREASE IN HOLLOW FIBER LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GAMBRO AB PLASMAFILTER PF 2000N AND EXCORIM KB MAXO PLASMAFILTER AND IS INDICATED FOR USE IN THERAPEUTIC PLASMAFILTRATION IN DISEASES WHERE REMOVAL OF PLASMA COMPONENTS ARE INDICTED, INCLUDING PLASMAFILT
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| AK 98 Dialysis Machine (955607) (K250508) | Vantive US Healthcare, LLC | 2025-08-01 |