Approval for the microny(tm) sr+ model 2425t single chamber rate adaptive pulse generator, which is programmed with the aps ii programmer with modle 3204a software, the apsu programmer, and the model 3500/3510 programmer with model 3304 software. The deivce is indicated for the following: 1) accepted patient conditions warranting chronic cardiac pacing which include: sick sinus syndrome; chronic, symptomatic second- and third-degree av block; recurrent adams-stokes syndrome; and symtomatic bilateral bundle branch block when tachy-arrhythmia and other causes have been ruled out. 2) atrial pacing in patients with sinus node dysfunction and normal av and intraventricular conduction systems. 3) ventricular pacing in patients with significant bradycardia and: normal sinus rhythm with only rare episodes of av block or sinus arrest requiring short periods of pacing support, chronic atrial fibrillation, and severe physical disability. 4) rate-modulated pacing in patients who would benefit from increased pacing rates concurrent with physical activity.
| Device | MICRONY PACEMAKERS |
| Classification Name | Pulse-generator, Single Chamber, Sensor Driven, Implantable |
| Generic Name | Pulse-generator, Single Chamber, Sensor Driven, Implantable |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 1997-01-03 |
| Decision Date | 2000-12-21 |
| Notice Date | 2001-01-16 |
| PMA | P970013 |
| Supplement | S |
| Product Code | LWO |
| Docket Number | 01M-0013 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970013 | | Original Filing |
| S091 |
2022-07-27 |
Real-time Process |
| S090 |
2022-03-07 |
Real-time Process |
| S089 |
2021-10-18 |
Real-time Process |
| S088 |
2021-06-28 |
30-day Notice |
| S087 |
2021-04-02 |
Real-time Process |
| S086 |
2021-03-12 |
30-day Notice |
| S085 | | |
| S084 |
2020-10-21 |
30-day Notice |
| S083 |
2020-02-13 |
30-day Notice |
| S082 | | |
| S081 |
2019-10-30 |
Real-time Process |
| S080 |
2018-11-20 |
30-day Notice |
| S079 |
2018-09-28 |
30-day Notice |
| S078 |
2018-07-17 |
30-day Notice |
| S077 |
2018-01-31 |
30-day Notice |
| S076 |
2018-01-18 |
Normal 180 Day Track |
| S075 |
2017-10-30 |
Real-time Process |
| S074 |
2017-10-10 |
30-day Notice |
| S073 |
2017-09-21 |
30-day Notice |
| S072 |
2017-08-16 |
30-day Notice |
| S071 |
2017-05-17 |
Normal 180 Day Track |
| S070 |
2017-02-07 |
Real-time Process |
| S069 |
2016-04-04 |
Real-time Process |
| S068 | | |
| S067 |
2015-10-26 |
135 Review Track For 30-day Notice |
| S066 |
2015-08-17 |
Normal 180 Day Track |
| S065 |
2015-08-10 |
30-day Notice |
| S064 |
2015-02-11 |
Normal 180 Day Track |
| S063 |
2014-12-18 |
Real-time Process |
| S062 | | |
| S061 | | |
| S060 |
2014-07-02 |
Normal 180 Day Track |
| S059 |
2014-05-28 |
30-day Notice |
| S058 |
2014-04-15 |
Real-time Process |
| S057 |
2013-11-21 |
Normal 180 Day Track |
| S056 |
2013-04-15 |
30-day Notice |
| S055 |
2012-12-05 |
Normal 180 Day Track |
| S054 |
2012-11-14 |
Normal 180 Day Track |
| S053 | | |
| S052 |
2012-09-13 |
30-day Notice |
| S051 |
2012-08-16 |
Real-time Process |
| S050 |
2012-07-11 |
Normal 180 Day Track |
| S049 |
2012-05-30 |
Real-time Process |
| S048 |
2012-04-03 |
30-day Notice |
| S047 |
2012-02-29 |
Real-time Process |
| S046 | | |
| S045 |
2011-11-30 |
135 Review Track For 30-day Notice |
| S044 |
2011-11-01 |
Normal 180 Day Track |
| S043 |
2011-08-31 |
Real-time Process |
| S042 |
2011-08-08 |
Real-time Process |
| S041 |
2011-06-28 |
Real-time Process |
| S040 |
2011-05-02 |
Normal 180 Day Track |
| S039 |
2011-02-28 |
30-day Notice |
| S038 |
2010-11-23 |
Normal 180 Day Track |
| S037 |
2010-10-12 |
30-day Notice |
| S036 |
2010-08-16 |
Normal 180 Day Track No User Fee |
| S035 |
2010-07-30 |
Real-time Process |
| S034 |
2010-06-04 |
Normal 180 Day Track |
| S033 |
2010-05-21 |
30-day Notice |
| S032 |
2009-10-02 |
135 Review Track For 30-day Notice |
| S031 |
2009-09-14 |
Real-time Process |
| S030 |
2009-06-18 |
30-day Notice |
| S029 |
2009-06-10 |
30-day Notice |
| S028 |
2008-12-31 |
Real-time Process |
| S027 |
2008-07-30 |
Real-time Process |
| S026 |
2008-06-13 |
30-day Notice |
| S025 |
2008-06-02 |
Real-time Process |
| S024 |
2008-05-21 |
30-day Notice |
| S023 |
2008-03-25 |
Real-time Process |
| S022 |
2007-10-24 |
Real-time Process |
| S021 |
2007-10-19 |
Normal 180 Day Track No User Fee |
| S020 |
2007-09-21 |
Real-time Process |
| S019 |
2007-04-23 |
Normal 180 Day Track |
| S018 |
2007-04-13 |
Real-time Process |
| S017 |
2007-04-06 |
Real-time Process |
| S016 |
2006-12-22 |
135 Review Track For 30-day Notice |
| S015 |
2006-12-20 |
135 Review Track For 30-day Notice |
| S014 |
2006-10-20 |
Real-time Process |
| S013 |
2006-10-06 |
Real-time Process |
| S012 |
2006-09-27 |
30-day Notice |
| S011 |
2006-07-13 |
30-day Notice |
| S010 |
2006-06-07 |
Real-time Process |
| S009 | | |
| S008 |
2006-03-30 |
Real-time Process |
| S007 |
2006-03-07 |
Real-time Process |
| S006 |
2006-02-17 |
Normal 180 Day Track |
| S005 |
2006-02-03 |
Real-time Process |
| S004 |
2006-01-25 |
Normal 180 Day Track |
| S003 |
2006-01-06 |
Real-time Process |
| S002 |
2001-09-28 |
30-day Notice |
| S001 |
2001-03-13 |
Normal 180 Day Track |
NIH GUDID Devices