Approval for changes to quality control and manufacturing procedures to include additional steps verifying that a minimum of 66 hours have elapsed between the time that the medstream pump battery is connected to the printed circuit board (pcb) and before programming the pcb with the production diagnostic pump software.
| Device | MEDSTREAM PROGRAMMABLE INFUSION SYSTEM |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | CODMAN |
| Date Received | 2014-04-28 |
| Decision Date | 2014-05-22 |
| PMA | P890055 |
| Supplement | S055 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CODMAN 325 Paramount Dr. raynham, MA 02767 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P890055 | | Original Filing |
| S083 |
2022-08-30 |
30-day Notice |
| S082 | | |
| S081 |
2022-05-27 |
Special (immediate Track) |
| S080 |
2022-04-26 |
30-day Notice |
| S079 |
2022-01-14 |
30-day Notice |
| S078 |
2021-11-23 |
30-day Notice |
| S077 |
2021-03-26 |
30-day Notice |
| S076 |
2020-11-17 |
30-day Notice |
| S075 | | |
| S074 | | |
| S073 |
2020-01-09 |
Normal 180 Day Track No User Fee |
| S072 |
2018-10-05 |
30-day Notice |
| S071 |
2017-12-13 |
30-day Notice |
| S070 |
2017-09-22 |
30-day Notice |
| S069 |
2017-08-21 |
Special (immediate Track) |
| S068 |
2017-06-08 |
30-day Notice |
| S067 |
2017-05-16 |
Real-time Process |
| S066 |
2017-02-01 |
30-day Notice |
| S065 |
2016-08-29 |
30-day Notice |
| S064 |
2016-08-02 |
30-day Notice |
| S063 |
2016-07-19 |
30-day Notice |
| S062 |
2016-04-27 |
30-day Notice |
| S061 |
2015-09-08 |
30-day Notice |
| S060 |
2015-06-24 |
30-day Notice |
| S059 |
2014-12-18 |
30-day Notice |
| S058 | | |
| S057 |
2014-06-06 |
Normal 180 Day Track No User Fee |
| S056 |
2014-05-01 |
Real-time Process |
| S055 |
2014-04-28 |
Special (immediate Track) |
| S054 | | |
| S053 |
2013-12-23 |
Special (immediate Track) |
| S052 |
2013-12-12 |
30-day Notice |
| S051 |
2013-08-30 |
30-day Notice |
| S050 |
2013-08-30 |
30-day Notice |
| S049 |
2013-08-22 |
Special (immediate Track) |
| S048 |
2013-06-28 |
Special (immediate Track) |
| S047 |
2012-11-07 |
Real-time Process |
| S046 |
2012-09-20 |
Real-time Process |
| S045 |
2012-09-13 |
Real-time Process |
| S044 | | |
| S043 |
2012-08-14 |
Real-time Process |
| S042 | | |
| S041 |
2012-05-29 |
30-day Notice |
| S040 |
2012-05-14 |
Real-time Process |
| S039 |
2012-03-16 |
Real-time Process |
| S038 |
2011-12-21 |
30-day Notice |
| S037 | | |
| S036 | | |
| S035 |
2011-09-30 |
135 Review Track For 30-day Notice |
| S034 |
2011-05-25 |
Special (immediate Track) |
| S033 |
2011-01-28 |
Real-time Process |
| S032 |
2011-03-01 |
Real-time Process |
| S031 |
2011-01-18 |
Normal 180 Day Track |
| S030 |
2011-01-18 |
Normal 180 Day Track No User Fee |
| S029 |
2011-01-18 |
Normal 180 Day Track No User Fee |
| S028 |
2011-01-18 |
Normal 180 Day Track No User Fee |
| S027 |
2010-11-24 |
30-day Notice |
| S026 |
2007-12-11 |
Normal 180 Day Track |
| S025 |
2007-12-11 |
Normal 180 Day Track |
| S024 |
2007-11-19 |
30-day Notice |
| S023 |
2007-10-23 |
Real-time Process |
| S022 | | |
| S021 |
2007-08-06 |
Normal 180 Day Track No User Fee |
| S020 |
2007-08-06 |
30-day Notice |
| S019 |
2006-09-28 |
Real-time Process |
| S018 |
2004-03-22 |
Real-time Process |
| S017 |
2003-11-24 |
Normal 180 Day Track No User Fee |
| S016 |
2003-07-16 |
Real-time Process |
| S015 |
2002-06-21 |
Normal 180 Day Track |
| S014 |
2002-03-07 |
Real-time Process |
| S013 |
2001-06-06 |
Normal 180 Day Track |
| S012 |
2001-04-02 |
Real-time Process |
| S011 |
1999-10-12 |
Real-time Process |
| S010 |
1999-05-11 |
Real-time Process |
| S009 |
1999-02-23 |
Normal 180 Day Track |
| S008 |
1999-02-05 |
Normal 180 Day Track |
| S007 |
1998-05-27 |
Normal 180 Day Track |
| S006 |
1997-09-30 |
Normal 180 Day Track |
| S005 |
1997-09-09 |
Normal 180 Day Track |
| S004 |
1997-06-24 |
Normal 180 Day Track |
| S003 |
1997-02-26 |
Normal 180 Day Track |
| S002 |
1996-06-28 |
Normal 180 Day Track |
| S001 |
1996-06-05 |
Normal 180 Day Track |
NIH GUDID Devices