B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM
FDA premarket approval P940016/S009 · decided 2002-09-20
Approval details
- PMA number
- P940016
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM
- Generic name
- Lipoprotein, low density, removal
- Applicant
- B. Braun Avitum AG
- Date received
- 2002-06-07
- Decision date
- 2002-09-20
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Melsungen
- Statement
- APPROVAL FOR 1) THE TRANSFER OF THE STERILIZATION PROCESS FOR THE BLOOD TUBING LINE COMPONENT OF B. BRAUN MEDICAL, INC.'S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM FROM ITS CURRENT, PMA APPROVED LOCATION TO THE B. BRAUN CAREX S.P.A. FACILITY; AND 2) THE PROPOSAL TO STERILIZE THE BLOOD TUBING LINES USING 10 PERCENT ETHYLENE OXIDE (ETO) AND 90 PERCENT CARBON DIOXIDE (CO2).
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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 |