H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM
FDA premarket approval P940016/S013 · decided 2010-07-22
Approval details
- PMA number
- P940016
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- B. Braun Avitum AG
- Date received
- 2009-09-30
- Decision date
- 2010-07-22
- Days to decision
- 295 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Melsungen
- Statement
- APPROVAL FOR DESIGN MODIFICATIONS TO THE PLASMAT SECURA SYSTEM INCLUDING THE USE OF THE PLASMAT FUTURA MACHINE WITH SOFTWARE VERSION 2.6.01, THE FUTURA KIT, AND INDIVIDUALLY PACKAGED COMPONENTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME H.E.L.P. PLASMAT FUTURA APHERESIS SYSTEM AND IS INDICATED FOR ACUTELY REMOVING LOW-DENSITY LIPOPROTEIN CHOLESTEROL (LDL-C) FROM THE PLASMA OF THE FOLLOWING HIGH-RISK PATIENT POPULATIONS FOR WHOM DIET HAS BEEN INEFFECTIVE AND MAXIMUM DRUG THER
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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 |