B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM

Lipoprotein, Low Density, Removal

FDA Premarket Approval P940016 S009

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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).

• Device: B.BRAUN,S HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P) SYSTEM
• Classification Name: Lipoprotein, Low Density, Removal
• Generic Name: Lipoprotein, Low Density, Removal
• Applicant: B. Braun Avitum AG
• Date Received: 2002-06-07
• Decision Date: 2002-09-20
• PMA: P940016
• Supplement: S009
• Product Code: MMY
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: B. Braun Avitum AG schwarzenberger Weg 73-79 melsungen D-342-3421

Supplemental Filings

Supplement Number	Date	Supplement Type
P940016		Original Filing
S027	2018-09-28	135 Review Track For 30-day Notice
S026	2018-06-15	135 Review Track For 30-day Notice
S025	2018-06-07	30-day Notice
S024	2017-10-11	30-day Notice
S023	2017-06-08	30-day Notice
S022	2016-10-17	30-day Notice
S021	2016-06-13	Real-time Process
S020	2015-11-02	135 Review Track For 30-day Notice
S019	2015-05-21	30-day Notice
S018	2015-05-21	30-day Notice
S017	2015-05-21	30-day Notice
S016	2013-09-13	Normal 180 Day Track
S015	2012-12-20	Real-time Process
S014	2011-07-19	Normal 180 Day Track
S013	2009-09-30	Normal 180 Day Track
S012	2009-02-19	Real-time Process
S011	2009-02-19	Real-time Process
S010
S009	2002-06-07	Normal 180 Day Track
S008
S007
S006
S005
S004	1998-12-15	Normal 180 Day Track
S003
S002
S001	1998-11-02	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
04046964699467	P940016	000
04046964133534	P940016	000
04046963847418	P940016	000
04046963845797	P940016	000
04046963845780	P940016	000
04046963845773	P940016	000
04046963845766	P940016	000
04046963711177	P940016	000
04046963711160	P940016	000
04046963711153	P940016	000
04046964156731	P940016	000
04046964231834	P940016	000
04046964696770	P940016	000
04046964695865	P940016	000
04046964337017	P940016	000
04046964319860	P940016	000
04046964290169	P940016	000
04046964290152	P940016	000
04046964290145	P940016	000
04046964290138	P940016	000
04046963711184	P940016	000
04046963711139	P940016	000