Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
FDA premarket approval P940016/S026 · decided 2019-05-22
Approval details
- PMA number
- P940016
- Supplement
- S026
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Heparin-Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
- Generic name
- Lipoprotein, low density, removal
- Applicant
- B. Braun Avitum AG
- Date received
- 2018-06-15
- Decision date
- 2019-05-22
- Days to decision
- 341 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Melsungen
- Statement
- Approval to change the test method for Total Blood Volume (TBV) and to remove TBV acceptance criteria for the batch release of the H.E.L.P. Ultrafilter HIPS 20.
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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 |