Approval for upgrading the existing accessory coolflow irrigation pump for the stockert 70 radiofrequency (rf) generator for cardiac ablation. The device, as modified, will be marketed under the trade name smartablate irrigation pump and smartablate tubing set. The indications are that the smartablate irrigation pump is a peristaltic pump designed to work in conjunction with the stockert 70 radiofrequency generator to deliver irrigation solution at specified now rates to irrigated catheters (such as the biosense webster celsius thermocool catheters and navistar thermocool catheters) for cooling purposes. The pump is used with the smartablate irrigation tubing set that conducts the irrigation solution from an external source to the compatible irrigated catheters.
| Device | STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2012-01-04 |
| Decision Date | 2012-10-31 |
| PMA | P990071 |
| Supplement | S016 |
| Product Code | LPB |
| 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