H.E.L.P. PLASMAT FUTURA SYSTEM
FDA premarket approval P940016/S015 · decided 2013-02-22
Approval details
- PMA number
- P940016
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- H.E.L.P. PLASMAT FUTURA SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- B. Braun Avitum AG
- Date received
- 2012-12-20
- Decision date
- 2013-02-22
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Melsungen
- Statement
- APPROVAL FOR AN INCREASE IN MEMBRANE LENGTH AND AN INCREASE INHOUSING LENGTH OF THE HEPARIN ADSORBER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEPARIN ADSORBER 400 AND IS INDICATED FOR USE AS A COMPONENT OF THE H.E.L.P FUTURA APHERESIS SYSTEM, USED FOR THE REMOVAL, BY IONIC EXCHANGE, OF EXCESS HEPARIN ADDED TO PRECIPITATE LIPOPROTEINS FROM PLASMA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Diacap Pro Dialyzer (K170574) | B. Braun Avitum AG | 2017-08-11 |
| xevonta dialyzer (K143482) | B. Braun Avitum AG | 2016-03-01 |
| SOLCART B (K102194) | B. Braun Avitum AG | 2011-04-25 |
| DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 (K100334) | B. Braun Avitum AG | 2010-04-22 |
| DIALOG WITH ADIMEA OPTION (K083460) | B. Braun Avitum AG | 2010-02-18 |