Approval to update the labeling for these devices to specifically state cephalad migration of catheter fragments as part of the adverse event summaries in the devices¿ information for prescribers manuals and user manuals.
| Device | SYNCHROMED EL/SYNCHROMED II/ISOMED PUMPS |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2010-09-07 |
| Decision Date | 2010-10-07 |
| PMA | P990034 |
| Supplement | S020 |
| 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 | Yes |
| 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