LIPOSORBER® LA-15 System

FDA Premarket Approval P910018 S030

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

A change in sterility tests for the sulflux kp-05 plasma separator

DeviceLIPOSORBER® LA-15 System
Generic NameLipoprotein, Low Density, Removal
ApplicantKANEKA PHARMA AMERICA CORP.
Date Received2021-03-31
Decision Date2021-04-29
PMAP910018
SupplementS030
Product CodeMMY 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address KANEKA PHARMA AMERICA CORP. 546 Fifth Ave., 21st Floor new York, NY 10036

Supplemental Filings

Supplement NumberDateSupplement Type
P910018Original Filing
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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