Approval for 1) adapter cables (models d-1170-27-001, d-1170-28-001, and d-1170-29-001) that connect the stockert 70 rf generator cable to compatible catheters and 2) a new indications for use for the stockert 70 rf generator. The adapter cables will be marketed under the trade name stockert 70 rf generator cable adapters for cardiac ablation. Both the stockert 70 rf generator cable adapters for cardiac ablation and stockert 70 rf generator are indicated for use in conjunction with a compatible catheter for cardiac ablation procedures.
| Device | STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR |
| Classification Name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Generic Name | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Applicant | BIOSENSE WEBSTER, INC. |
| Date Received | 2001-11-29 |
| Decision Date | 2002-02-15 |
| PMA | P990071 |
| Supplement | S002 |
| Product Code | DRF |
| 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