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 dual 8 ablation catheter and ibi 1500t9 rf ablation generator. The therapy dual 8 ablation catheter is intended for use with the ibi 1500t9 radiofrequency (rf) ablation generator at a maximum of 100 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. 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 limited to 100 watts when used with the therapy dual 8 ablation catheters.
| Device | THERAPY DUAL 8 ABLATION CATHETER & IBI-1500T6 CARDIAC ABLATION GENERATOR |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
| Applicant | IRVINE BIOMEDICAL,INC.(IBI) |
| Date Received | 2007-02-12 |
| Decision Date | 2007-03-16 |
| PMA | P040042 |
| Supplement | S008 |
| Product Code | OAD |
| 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.(IBI) 2375 Morse Ave. irvine, CA 92614 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040042 | | Original Filing |
| S054 |
2022-11-14 |
30-day Notice |
| S053 | | |
| S052 |
2022-10-19 |
Normal 180 Day Track No User Fee |
| S051 |
2021-09-14 |
30-day Notice |
| S050 |
2021-04-13 |
30-day Notice |
| S049 |
2021-02-25 |
30-day Notice |
| S048 |
2021-01-13 |
Real-time Process |
| S047 |
2020-09-18 |
30-day Notice |
| S046 | | |
| S045 |
2020-02-20 |
Real-time Process |
| S044 |
2020-02-04 |
30-day Notice |
| S043 |
2019-07-29 |
30-day Notice |
| S042 |
2019-03-15 |
30-day Notice |
| S041 |
2018-12-12 |
Special (immediate Track) |
| S040 |
2018-02-05 |
30-day Notice |
| S039 | | |
| S038 | | |
| S037 |
2017-05-04 |
30-day Notice |
| S036 |
2016-08-12 |
30-day Notice |
| S035 |
2016-05-27 |
30-day Notice |
| S034 |
2016-02-19 |
30-day Notice |
| S033 |
2015-11-20 |
Real-time Process |
| S032 |
2015-09-23 |
30-day Notice |
| S031 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S030 |
2015-04-20 |
30-day Notice |
| S029 |
2014-11-07 |
Real-time Process |
| S028 |
2014-04-30 |
Normal 180 Day Track No User Fee |
| S027 |
2014-03-03 |
Real-time Process |
| S026 |
2013-11-27 |
Normal 180 Day Track |
| S025 |
2013-08-30 |
30-day Notice |
| S024 |
2011-11-29 |
135 Review Track For 30-day Notice |
| S023 |
2011-10-14 |
30-day Notice |
| S022 |
2011-05-09 |
30-day Notice |
| S021 |
2011-01-18 |
30-day Notice |
| S020 |
2010-11-16 |
Real-time Process |
| S019 | | |
| S018 |
2010-02-22 |
30-day Notice |
| S017 |
2009-12-14 |
30-day Notice |
| S016 |
2009-07-30 |
30-day Notice |
| S015 |
2009-05-04 |
30-day Notice |
| S014 |
2008-11-10 |
30-day Notice |
| S013 |
2008-09-04 |
Normal 180 Day Track |
| S012 |
2008-05-14 |
30-day Notice |
| S011 |
2007-09-19 |
30-day Notice |
| S010 |
2007-03-16 |
30-day Notice |
| S009 |
2007-03-12 |
Normal 180 Day Track |
| S008 |
2007-02-12 |
Real-time Process |
| S007 |
2006-12-18 |
135 Review Track For 30-day Notice |
| S006 |
2006-09-05 |
Normal 180 Day Track |
| S005 |
2006-08-18 |
Real-time Process |
| S004 |
2006-08-01 |
Real-time Process |
| S003 |
2006-06-02 |
Real-time Process |
| S002 |
2006-05-01 |
Real-time Process |
| S001 |
2005-11-22 |
30-day Notice |
NIH GUDID Devices