Heparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System

Lipoprotein, Low Density, Removal

FDA Premarket Approval P940016 S023

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

Qualification of an additional clean room area for the b. Braun avitum italy plant for the manufacturing of the h. E. L. P futura set.

DeviceHeparin_Induced Extracorporeal LDL Precipitation (H.E.L.P.) Futura Apheresis System
Classification NameLipoprotein, Low Density, Removal
Generic NameLipoprotein, Low Density, Removal
ApplicantB. Braun Avitum AG
Date Received2017-06-08
Decision Date2017-07-06
PMAP940016
SupplementS023
Product CodeMMY
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address B. Braun Avitum AG schwarzenberger Weg 73-79 melsungen D-342-3421

Supplemental Filings

Supplement NumberDateSupplement Type
P940016Original 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 IDPMASupp
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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

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