IsoMed Infusion System

FDA Premarket Approval P990034 S043

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 NumberS043 Date Received08/19/2022 Decision Date09/16/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-08-19
Decision Date2022-09-16
PMAP990034
SupplementS043
Product CodeLKK 
Advisory CommitteeGeneral Hospital
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressMEDTRONIC Inc.
7000 Central Avenue Ne
minneapolis, MN 55432-3576 PMA NumberP990034 Supplement NumberS043 Date Received08/19/2022 Decision Date09/16/2022 Product Code LKK  Advisory Committee General Hospital Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
for Labeling Updates For The Targeted Drug Delivery (TDD) Therapy Labeling

Supplemental Filings

Supplement NumberDateSupplement Type
P990034Original Filing
S043 2022-08-19 Special (immediate Track)
S042 2022-07-22 Special (immediate Track)
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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