Approval for the following device modifications:1) reduced recommended saline flow rate (reduce by ~50%); 2) increase in number of irrigation holes (from 6 to 56); 3) decrease in size of irrigation holes (from 0. 016" to 0. 0035" diameter);4) modified tip electrode material (from 90% platinum/10% iridium to 80% palladium/20% platinum); and 5) update stockert 70 rf generator software (vl. 035 to vl. 037). The device, as modified, will be marketed under the trade names bi-directional carto xp thermocool sf nay catheter, bi-directional carto 3 thermocool sf nay catheter, and bidirectional thermocool sf catheter and is indicated for: the biosense webster thermocool sf nav diagnostic/ ablation deflectable tip catheter and related accessory devices are indicated for catheter based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of 1) type i atrial flutter in patients age 18 or older; and 2) drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The thermocool sf nav diagnostic/ ablation deflectable tip catheter provides location information when used with compatible carto ep navigation systems. The biosense webster thermocool sf diagnostic/ablation deflectable tip catheter and related accessories are indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with a compatible rf generator, for the treatment of type i atrial flutter in patients age 18 or older.
| Device | THERMOCOOL SF NAV BI-DIRECTIONAL CATHETER (D1313-XX-S, D-1317-XX-S) AND THERMOCOOL SF BI-DIRECTIONAL CATHETER |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2010-01-15 |
| Decision Date | 2011-12-21 |
| PMA | P990071 |
| Supplement | S009 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BIOSENSE WEBSTER, INC. 33 Technology Drive irvine, CA 92618 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990071 | | Original Filing |
| S056 |
2022-09-02 |
30-day Notice |
| S055 | | |
| S054 |
2022-05-18 |
30-day Notice |
| S053 |
2022-02-16 |
30-day Notice |
| S052 |
2021-08-23 |
Normal 180 Day Track No User Fee |
| S051 | | |
| S050 |
2021-06-11 |
30-day Notice |
| S049 |
2021-04-12 |
30-day Notice |
| S048 |
2021-03-31 |
30-day Notice |
| S047 | | |
| S046 | | |
| S045 |
2020-09-08 |
30-day Notice |
| S044 |
2020-04-20 |
Normal 180 Day Track |
| S043 |
2020-03-13 |
30-day Notice |
| S042 |
2019-01-03 |
Real-time Process |
| S041 |
2018-07-02 |
30-day Notice |
| S040 |
2018-06-20 |
Normal 180 Day Track No User Fee |
| S039 |
2018-05-21 |
Special (immediate Track) |
| S038 |
2017-10-03 |
30-day Notice |
| S037 |
2017-09-11 |
Normal 180 Day Track |
| S036 |
2017-06-02 |
Real-time Process |
| S035 |
2017-05-23 |
Special (immediate Track) |
| S034 |
2016-06-13 |
Normal 180 Day Track |
| S033 |
2016-05-09 |
Normal 180 Day Track |
| S032 |
2015-08-17 |
Special (immediate Track) |
| S031 |
2015-05-18 |
30-day Notice |
| S030 |
2014-11-10 |
30-day Notice |
| S029 |
2014-09-10 |
Real-time Process |
| S028 |
2014-07-02 |
Normal 180 Day Track No User Fee |
| S027 |
2014-04-07 |
Normal 180 Day Track |
| S026 | | |
| S025 |
2013-12-27 |
30-day Notice |
| S024 |
2013-08-09 |
30-day Notice |
| S023 |
2013-04-29 |
Real-time Process |
| S022 |
2013-03-27 |
30-day Notice |
| S021 | | |
| S020 |
2012-08-17 |
Real-time Process |
| S019 |
2012-06-19 |
30-day Notice |
| S018 |
2012-06-19 |
Normal 180 Day Track |
| S017 |
2012-04-16 |
Normal 180 Day Track |
| S016 |
2012-01-04 |
Normal 180 Day Track |
| S015 |
2011-08-29 |
30-day Notice |
| S014 | | |
| S013 |
2011-06-20 |
Normal 180 Day Track |
| S012 |
2011-03-01 |
30-day Notice |
| S011 |
2010-03-17 |
Special (immediate Track) |
| S010 |
2010-03-02 |
Normal 180 Day Track No User Fee |
| S009 |
2010-01-15 |
Normal 180 Day Track |
| S008 |
2006-03-01 |
Real-time Process |
| S007 |
2005-04-11 |
Normal 180 Day Track |
| S006 |
2005-02-17 |
Special (immediate Track) |
| S005 |
2003-12-22 |
Normal 180 Day Track |
| S004 |
2003-11-05 |
Real-time Process |
| S003 |
2002-10-01 |
Real-time Process |
| S002 |
2001-11-29 |
Normal 180 Day Track |
| S001 |
2000-06-28 |
Normal 180 Day Track |
NIH GUDID Devices