Approval for the therapy dual 8 cardiac ablation system. The device is indicated for the treatment of typical atrial flutter.
| Device | THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION 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.(IBI) |
| Date Received | 2004-10-04 |
| Decision Date | 2005-11-18 |
| Notice Date | 2005-11-28 |
| PMA | P040042 |
| Supplement | S |
| Product Code | OAD |
| Docket Number | 05M-0476 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | IRVINE BIOMEDICAL,INC.(IBI) 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 |
|---|
| 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