Approval for changes to thermal and egm boards, upgrade to thefirmware and software, addition of remote control fiber cord lengths and updates to the instruction for use of the ampere generator.
| Device | THERAPY DUAL 8 CATHETER (NON-IRRIGATED), THERAPY 8MM THERMISTOR ABLATION CATHERER (NON-IRRIGATED) SAFIRE TX CATHETER (NO |
| 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 | 2014-03-03 |
| Decision Date | 2014-04-28 |
| PMA | P040042 |
| Supplement | S027 |
| 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