Approval of the post-approval study protocol.
| Device | MEDSTREAM PROGRAMMABLE INFUSION SYSTEM |
| Classification Name | Pump, Infusion, Implanted, Programmable |
| Generic Name | Pump, Infusion, Implanted, Programmable |
| Applicant | CODMAN |
| Date Received | 2011-01-18 |
| Decision Date | 2011-03-15 |
| PMA | P890055 |
| Supplement | S029 |
| Product Code | LKK |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| 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