H.E.L.P. SYSTEM
FDA premarket approval P940016 · decided 1997-09-19
Approval details
- PMA number
- P940016
- Trade name
- H.E.L.P. SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- B. Braun Avitum AG
- Date received
- 1994-06-01
- Decision date
- 1997-09-19
- Days to decision
- 1206 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Melsungen
- Statement
- Approval for the H.E.L.P. System. The device is a low density lipoprotein cholesterol (LDL-C) apheresis system, indicated for use in perofrming LDL-C apheresis to acutely remove LDL-C from the plasma of high risk patient populations for whom diet has been ineffective or not tolerated.
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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 |