Approval for software fixes and enhancements for the ampere rf generator, including file system modifications, system log changes, and revised communication to compatible recording systems and the cool point irrigation pump.
| Device | THERAPY DUAL 8, THERAPY 8MM THERMISTOR, AND SAFIRE TX ABLATION CATHETERS, AND 1500T6 AND 1500T9 RF 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 | 2015-11-20 |
| Decision Date | 2016-02-18 |
| PMA | P040042 |
| Supplement | S033 |
| 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