Approval for the blazer open-irrigated ablation catheter, when used with a maestro 4000 radiofrequency (rf) controller and metriq irrigation pump, is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and radiofrequency ablation of sustained or recurrent type i atrial flutter (afl) in patients age 18 or older.
| Device | BLAZER OPEN-IRRIGATED ABLATION CATHETER |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | Boston Scientific Corp. |
| Date Received | 2015-02-02 |
| Decision Date | 2016-02-24 |
| Notice Date | 2016-03-07 |
| PMA | P150005 |
| Supplement | S |
| Product Code | OAD |
| Docket Number | 16M-0807 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150005 | | Original Filing |
| S073 |
2022-10-17 |
30-day Notice |
| S072 |
2022-08-26 |
Real-time Process |
| S071 |
2022-08-22 |
30-day Notice |
| S070 |
2022-01-28 |
30-day Notice |
| S069 |
2022-01-24 |
30-day Notice |
| S068 |
2021-11-10 |
30-day Notice |
| S067 |
2021-08-13 |
30-day Notice |
| S066 |
2021-07-08 |
30-day Notice |
| S065 |
2021-06-25 |
30-day Notice |
| S064 |
2021-06-24 |
30-day Notice |
| S063 |
2021-06-21 |
30-day Notice |
| S062 |
2021-02-22 |
Normal 180 Day Track No User Fee |
| S061 | | |
| S060 |
2020-11-16 |
30-day Notice |
| S059 |
2020-11-12 |
30-day Notice |
| S058 |
2020-09-29 |
Normal 180 Day Track |
| S057 |
2020-09-28 |
Real-time Process |
| S056 |
2020-05-21 |
30-day Notice |
| S055 |
2020-05-15 |
30-day Notice |
| S054 |
2020-04-30 |
Normal 180 Day Track No User Fee |
| S053 |
2020-03-12 |
Normal 180 Day Track No User Fee |
| S052 |
2020-01-22 |
30-day Notice |
| S051 |
2019-11-22 |
Real-time Process |
| S050 |
2019-10-10 |
30-day Notice |
| S049 | | |
| S048 |
2019-09-30 |
30-day Notice |
| S047 |
2019-06-14 |
Real-time Process |
| S046 |
2019-05-08 |
30-day Notice |
| S045 | | |
| S044 |
2019-04-08 |
30-day Notice |
| S043 | | |
| S042 |
2019-03-20 |
30-day Notice |
| S041 |
2018-10-25 |
135 Review Track For 30-day Notice |
| S040 |
2018-08-24 |
30-day Notice |
| S039 |
2018-06-21 |
Normal 180 Day Track |
| S038 |
2018-06-13 |
30-day Notice |
| S037 |
2018-04-27 |
Normal 180 Day Track No User Fee |
| S036 |
2018-04-06 |
135 Review Track For 30-day Notice |
| S035 |
2018-02-02 |
Normal 180 Day Track |
| S034 |
2018-01-17 |
30-day Notice |
| S033 |
2017-12-15 |
Real-time Process |
| S032 |
2017-10-30 |
30-day Notice |
| S031 |
2017-10-26 |
30-day Notice |
| S030 |
2017-10-02 |
30-day Notice |
| S029 |
2017-09-15 |
30-day Notice |
| S028 |
2017-09-14 |
30-day Notice |
| S027 |
2017-08-30 |
30-day Notice |
| S026 |
2017-08-25 |
30-day Notice |
| S025 |
2017-08-14 |
30-day Notice |
| S024 |
2017-08-04 |
30-day Notice |
| S023 |
2017-07-18 |
30-day Notice |
| S022 |
2017-06-26 |
30-day Notice |
| S021 |
2017-05-18 |
30-day Notice |
| S020 |
2017-04-27 |
Real-time Process |
| S019 |
2017-04-13 |
30-day Notice |
| S018 |
2017-03-17 |
30-day Notice |
| S017 |
2017-03-16 |
Normal 180 Day Track |
| S016 |
2017-03-06 |
30-day Notice |
| S015 |
2017-03-03 |
Real-time Process |
| S014 |
2017-02-22 |
Panel Track |
| S013 |
2016-11-17 |
Normal 180 Day Track No User Fee |
| S012 |
2016-11-09 |
30-day Notice |
| S011 |
2016-11-07 |
135 Review Track For 30-day Notice |
| S010 |
2016-07-21 |
30-day Notice |
| S009 |
2016-07-21 |
30-day Notice |
| S008 |
2016-05-02 |
Normal 180 Day Track |
| S007 |
2016-04-15 |
135 Review Track For 30-day Notice |
| S006 |
2016-04-11 |
Normal 180 Day Track No User Fee |
| S005 |
2016-04-11 |
Normal 180 Day Track |
| S004 |
2016-03-21 |
135 Review Track For 30-day Notice |
| S003 | | |
| S002 |
2016-03-01 |
30-day Notice |
| S001 |
2016-03-01 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices