Approval for a new coagulopathies warning.
| Device | ISOMED INFUSION SYSTEM |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2008-11-28 |
| Decision Date | 2009-02-06 |
| PMA | P990034 |
| Supplement | S012 |
| 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 |
Supplemental Filings
| 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 |
NIH GUDID Devices