IsoMed Infusion System

FDA Premarket Approval P990034 S041

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

DeviceIsoMed Infusion System
Generic NamePump, Infusion, Implanted, Programmable
ApplicantMEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP990034 Supplement NumberS041 Date Received05/13/2022 Decision Date06/09/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-13
Decision Date2022-06-09
PMAP990034
SupplementS041
Product CodeLKK 
Advisory CommitteeGeneral Hospital
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC Inc.
7000 Central Avenue Ne
minneapolis, MN 55432-3576 PMA NumberP990034 Supplement NumberS041 Date Received05/13/2022 Decision Date06/09/2022 Product Code LKK  Advisory Committee General Hospital Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Revision To The Manufacturing Execution System Used In Several Facilities For The Subject Devices.

Supplemental Filings

Supplement NumberDateSupplement Type
P990034Original Filing
S041 2022-05-13 30-day Notice
S040
S039 2019-07-12 Normal 180 Day Track
S038 2018-01-30 30-day Notice
S037
S036 2017-03-14 Special (immediate Track)
S035 2016-11-14 30-day Notice
S034
S033 2014-09-16 30-day Notice
S032 2014-06-04 30-day Notice
S031 2014-05-12 Real-time Process
S030
S029 2012-11-21 Special (immediate Track)
S028
S027
S026 2011-11-08 30-day Notice
S025 2011-11-07 Normal 180 Day Track No User Fee
S024 2011-07-22 30-day Notice
S023 2011-06-29 30-day Notice
S022 2011-05-18 30-day Notice
S021 2010-12-07 30-day Notice
S020 2010-09-07 Special (immediate Track)
S019 2010-06-28 30-day Notice
S018 2010-04-20 Special (immediate Track)
S017 2010-03-19 30-day Notice
S016 2010-01-28 Special (immediate Track)
S015 2010-01-07 Real-time Process
S014 2009-10-01 Special (immediate Track)
S013 2009-07-09 Special (immediate Track)
S012 2008-11-28 Special (immediate Track)
S011 2008-07-24 135 Review Track For 30-day Notice
S010 2007-08-20 Special (immediate Track)
S009
S008
S007
S006 2005-12-02 Normal 180 Day Track
S005 2004-12-10 Special (immediate Track)
S004 2003-06-18 Special (immediate Track)
S003 2002-09-04 Normal 180 Day Track
S002 2002-02-25 Real-time Process
S001 2000-10-30 Real-time Process

NIH GUDID Devices

Device IDPMASupp
00681490184328 P990034 003
00681490184311 P990034 003
00643169072664 P990034 025
00643169100961 P990034 029
00643169395060 P990034 029

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