LIPOSORBER LA-15 System

FDA Premarket Approval P910018 S033

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

DeviceLIPOSORBER LA-15 System
Generic NameLipoprotein, Low Density, Removal
ApplicantKANEKA PHARMA AMERICA CORP.546 Fifth Ave., 21st Floornew York, NY 10036 PMA NumberP910018 Supplement NumberS033 Date Received03/30/2022 Decision Date04/29/2022 Product Code MMY  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-30
Decision Date2022-04-29
PMAP910018
SupplementS033
Product CodeMMY 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressKANEKA PHARMA AMERICA CORP.
546 Fifth Ave., 21st Floor
new York, NY 10036 PMA NumberP910018 Supplement NumberS033 Date Received03/30/2022 Decision Date04/29/2022 Product Code MMY  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
qualification Of New Equipment For The EVOH Coating Process And The Hollow Fiber (HF) Drying Process To Increase Hollow Fiber Production Capacity .

Supplemental Filings

Supplement NumberDateSupplement Type
P910018Original Filing
S033 2022-03-30 30-day Notice
S032 2021-12-17 Special (immediate Track)
S031 2021-06-28 30-day Notice
S030 2021-03-31 30-day Notice
S029
S028 2020-11-27 30-day Notice
S027 2019-08-13 Normal 180 Day Track
S026 2019-04-23 30-day Notice
S025 2018-03-29 30-day Notice
S024 2018-03-01 30-day Notice
S023 2018-02-16 Normal 180 Day Track
S022 2017-03-31 Normal 180 Day Track
S021 2016-07-29 Normal 180 Day Track
S020 2016-04-20 Normal 180 Day Track
S019 2016-04-08 30-day Notice
S018 2016-02-16 30-day Notice
S017 2015-04-10 Normal 180 Day Track
S016 2012-05-21 30-day Notice
S015 2011-11-08 Normal 180 Day Track
S014
S013 2009-10-27 Normal 180 Day Track No User Fee
S012 2006-09-08 Normal 180 Day Track
S011 2006-04-20 Normal 180 Day Track
S010
S009 2003-01-15 30-day Notice
S008
S007 2000-08-22 Normal 180 Day Track
S006 2000-08-07 30-day Notice
S005 2000-06-20 Normal 180 Day Track
S004
S003
S002 1998-12-15 Normal 180 Day Track
S001 1998-11-02 Normal 180 Day Track

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