Approval for changes to the implant manuals for the following sutureless connector catheters: model 8709sc indura 1p one-piece intrathecal catheter with sutureless connector, model 8731sc intrathecal catheter with sutureless connector, model 8578 sutureless pump connector revision kit, and model 8696sc intrathecal catheter pump segment revision kit with sutureless connector.
| Device | SYNCHROMED & ISOMED DRUG INFUSION SYSTEMS |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2009-10-01 |
| Decision Date | 2009-10-30 |
| PMA | P990034 |
| Supplement | S014 |
| 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