Approval to add bi-directional steering to the therapy cool path ablation catheter. The devices, as modified, will be marketed under the trade names safire blu irrigated ablation catheter and therapy cool path ablation catheter.
| Device | SAFIRE BLU IRRIGATED ABLATION CATHETER & THERAPY COOL PATH CATHETER |
| 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 | 2009-05-14 |
| Decision Date | 2011-02-23 |
| PMA | P060019 |
| Supplement | S009 |
| Product Code | OAD |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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 |
|---|
| 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