Approval for the therapy cool path ablation catheter and ibi 1500t9 rf ablation generator. The therapy cool path ablation catheter is intended for use with a compatible external infusion pump and the ibi 1500t9 radiofrequency (rf) generator at a maximum of 50 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 internally limited to 50 watts when used with the therapy cool path catheters. A compatible external infusion pump must be connected when used with therapy cool path catheters.
| Device | IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF |
| 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. |
| Date Received | 2006-05-30 |
| Decision Date | 2007-03-16 |
| Notice Date | 2007-03-26 |
| PMA | P060019 |
| Supplement | S |
| Product Code | OAD |
| Docket Number | 07M-0108 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | IRVINE BIOMEDICAL, INC. 2375 Morse Ave. irvine, CA 92614 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P060019 | | Original Filing |
| S054 |
2021-09-14 |
30-day Notice |
| S053 |
2021-04-19 |
30-day Notice |
| S052 |
2021-04-13 |
30-day Notice |
| S051 |
2021-02-25 |
30-day Notice |
| S050 |
2021-01-13 |
Real-time Process |
| S049 |
2020-09-18 |
30-day Notice |
| S048 | | |
| S047 |
2020-02-20 |
Real-time Process |
| S046 |
2020-02-04 |
30-day Notice |
| S045 |
2019-03-15 |
30-day Notice |
| S044 |
2018-12-12 |
Special (immediate Track) |
| S043 | | |
| S042 |
2018-02-05 |
30-day Notice |
| S041 |
2017-09-11 |
Real-time Process |
| S040 | | |
| S039 |
2017-05-04 |
30-day Notice |
| S038 |
2016-08-12 |
30-day Notice |
| S037 |
2016-05-27 |
30-day Notice |
| S036 |
2016-02-19 |
30-day Notice |
| S035 |
2015-11-20 |
Real-time Process |
| S034 |
2015-09-23 |
30-day Notice |
| S033 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S032 |
2015-05-15 |
Normal 180 Day Track No User Fee |
| S031 |
2015-04-20 |
30-day Notice |
| S030 |
2014-11-07 |
Real-time Process |
| S029 |
2014-09-09 |
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 |
2013-09-25 |
Normal 180 Day Track |
| S024 |
2013-08-30 |
30-day Notice |
| S023 |
2012-07-11 |
135 Review Track For 30-day Notice |
| S022 |
2012-07-10 |
Real-time Process |
| S021 |
2012-05-11 |
Real-time Process |
| S020 |
2011-11-29 |
135 Review Track For 30-day Notice |
| S019 |
2011-10-14 |
30-day Notice |
| S018 | | |
| S017 |
2011-01-18 |
30-day Notice |
| S016 |
2010-11-30 |
30-day Notice |
| S015 |
2010-11-16 |
Real-time Process |
| S014 |
2010-09-29 |
30-day Notice |
| S013 |
2010-08-30 |
Normal 180 Day Track |
| S012 | | |
| S011 |
2010-02-22 |
30-day Notice |
| S010 |
2009-12-14 |
30-day Notice |
| S009 |
2009-05-14 |
Normal 180 Day Track |
| S008 |
2009-05-04 |
30-day Notice |
| S007 |
2008-11-10 |
30-day Notice |
| S006 | | |
| S005 |
2008-07-14 |
Normal 180 Day Track |
| S004 |
2008-04-14 |
Real-time Process |
| S003 |
2007-06-07 |
Real-time Process |
| S002 |
2007-05-31 |
Real-time Process |
| S001 |
2007-03-30 |
135 Review Track For 30-day Notice |
NIH GUDID Devices