Approval for a new rf generator, which includes software and hardware modifications to the previously approved rf generator. The device, as modified, will be marketed under the trade name therapy ablation catheter and ibi 1500t9 rt ablation generator. The therapy ablation catheter is indicated for mapping and for use with the ibi 1500t9 radiofrequency (rf) generator at a maximum of 50 watts for: interruption of accessory atrioventricular (av) conduction pathways associated with tachycardia; the treatment of av nodal re-entrant tachycardia (avnrt); or creation of complete av nodal block in patients with a difficult to control ventricular response to an atrial arrhythmia. The ibi 1500t9 rf ablation generator is intended for use with compatible st. Jude medical temperature controlled ablation catheters for creating endocardial lesions to treat cardiac arrhythmias (i. E. Supraventricular tachycardias, and atrial flutter). The generator is internally limited to 50 watts when used with the therapy ablation catheters.
| Device | IBI THERAPY CARDIAC ABLATION SYSTEM |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | IRVINE BIOMEDICAL, INC. |
| Date Received | 2007-02-12 |
| Decision Date | 2007-03-16 |
| PMA | P040014 |
| Supplement | S006 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | IRVINE BIOMEDICAL, INC. 2375 Morse Ave. irvine, CA 92614 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040014 | | Original Filing |
| S047 |
2022-10-28 |
Normal 180 Day Track No User Fee |
| S046 |
2022-10-19 |
Normal 180 Day Track No User Fee |
| S045 |
2021-09-14 |
30-day Notice |
| S044 |
2021-04-13 |
30-day Notice |
| S043 |
2021-02-25 |
30-day Notice |
| S042 |
2021-01-13 |
Real-time Process |
| S041 |
2020-09-18 |
30-day Notice |
| S040 | | |
| S039 |
2020-02-20 |
Real-time Process |
| S038 |
2020-02-04 |
30-day Notice |
| S037 |
2019-07-29 |
30-day Notice |
| S036 |
2019-03-15 |
30-day Notice |
| S035 |
2018-12-12 |
Special (immediate Track) |
| S034 |
2018-02-05 |
30-day Notice |
| S033 | | |
| S032 |
2017-05-04 |
30-day Notice |
| S031 |
2016-08-12 |
30-day Notice |
| S030 |
2016-05-27 |
30-day Notice |
| S029 |
2016-02-19 |
30-day Notice |
| S028 |
2015-11-20 |
Real-time Process |
| S027 |
2015-09-23 |
30-day Notice |
| S026 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S025 |
2015-04-20 |
30-day Notice |
| S024 |
2014-11-07 |
Real-time Process |
| S023 |
2014-04-30 |
Normal 180 Day Track No User Fee |
| S022 |
2014-03-03 |
Real-time Process |
| S021 |
2013-11-27 |
Normal 180 Day Track |
| S020 |
2013-08-30 |
30-day Notice |
| S019 |
2011-11-29 |
135 Review Track For 30-day Notice |
| S018 |
2011-10-14 |
30-day Notice |
| S017 |
2011-05-09 |
30-day Notice |
| S016 |
2011-01-18 |
30-day Notice |
| S015 |
2010-11-16 |
Real-time Process |
| S014 | | |
| S013 |
2010-02-22 |
30-day Notice |
| S012 |
2009-12-14 |
30-day Notice |
| S011 |
2009-07-30 |
30-day Notice |
| S010 |
2009-05-04 |
30-day Notice |
| S009 |
2008-11-10 |
30-day Notice |
| S008 |
2008-09-04 |
Normal 180 Day Track |
| S007 |
2008-05-14 |
30-day Notice |
| S006 |
2007-02-12 |
Real-time Process |
| S005 |
2006-12-18 |
135 Review Track For 30-day Notice |
| S004 |
2006-09-05 |
Normal 180 Day Track |
| S003 |
2006-06-12 |
Normal 180 Day Track |
| S002 |
2005-11-09 |
30-day Notice |
| S001 |
2005-04-01 |
Normal 180 Day Track |
NIH GUDID Devices