HEPARIN-INDUCED EXTRACORPOREAL LDL-PRECIPITATION (H.E.L.P.) FUTURA APHERESIS SYSTEM
FDA premarket approval P940016/S018 · decided 2015-06-16
Approval details
- PMA number
- P940016
- Supplement
- S018
- Supplement type
- 30-Day Notice
- 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
- 2015-05-21
- Decision date
- 2015-06-16
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MMY
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Melsungen
- Statement
- REDUCTION IN TESTING AMOUNT FOR ALUMINUM DETERMINATION DURING IN-PROCESS CONTROLS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |