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.
| Device | IsoMed Infusion System |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | MEDTRONIC Inc.7000 Central Avenue Neminneapolis, MN 55432-3576 PMA NumberP990034 Supplement NumberS042 Date Received07/22/2022 Decision Date08/19/2022 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 Received | 2022-07-22 |
| Decision Date | 2022-08-19 |
| PMA | P990034 |
| Supplement | S042 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC Inc. 7000 Central Avenue Ne minneapolis, MN 55432-3576 PMA NumberP990034 Supplement NumberS042 Date Received07/22/2022 Decision Date08/19/2022 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 Approval Of Labeling Changes For The Catheter Access Port Kit Used With The IsoMed Infusion System |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990034 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00681490184328 | P990034 | 003 |
| 00681490184311 | P990034 | 003 |
| 00643169072664 | P990034 | 025 |
| 00643169100961 | P990034 | 029 |
| 00643169395060 | P990034 | 029 |