Approval for expanded indications for use to include the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The devices, as modified, will be marketed under the trade name intellatip mifi open-irrigated ablation catheter and intellanav mifi open-irrigated ablation catheter when used with a compatible radiofrequency controller and irrigation pump, are indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, radiofrequency ablation of sustain or recurrent type 1 atrial flutter in patients age 18 or older, and treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (paf) in patients age 18 years or older, when used with a compatible mapping system.
| Device | Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters |
| 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 | 2018-02-02 |
| Decision Date | 2018-08-01 |
| PMA | P150005 |
| Supplement | S035 |
| Product Code | OAD |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corp. 150 Baytech Drive san Jose, CA 95134 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
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