Approval of 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 ABLATION CATHETERS |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | IRVINE BIOMEDICAL, INC. |
| Date Received | 2015-11-20 |
| Decision Date | 2016-02-18 |
| PMA | P040014 |
| Supplement | S028 |
| Product Code | LPB |
| 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. 2375 Morse Ave. irvine, CA 92614 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040014 | | Original Filing |
| S047 |
2022-10-28 |
Normal 180 Day Track No User Fee |
| S046 |
2022-10-19 |
Normal 180 Day Track No User Fee |
| S045 |
2021-09-14 |
30-day Notice |
| S044 |
2021-04-13 |
30-day Notice |
| S043 |
2021-02-25 |
30-day Notice |
| S042 |
2021-01-13 |
Real-time Process |
| S041 |
2020-09-18 |
30-day Notice |
| S040 | | |
| S039 |
2020-02-20 |
Real-time Process |
| S038 |
2020-02-04 |
30-day Notice |
| S037 |
2019-07-29 |
30-day Notice |
| S036 |
2019-03-15 |
30-day Notice |
| S035 |
2018-12-12 |
Special (immediate Track) |
| S034 |
2018-02-05 |
30-day Notice |
| S033 | | |
| S032 |
2017-05-04 |
30-day Notice |
| S031 |
2016-08-12 |
30-day Notice |
| S030 |
2016-05-27 |
30-day Notice |
| S029 |
2016-02-19 |
30-day Notice |
| S028 |
2015-11-20 |
Real-time Process |
| S027 |
2015-09-23 |
30-day Notice |
| S026 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S025 |
2015-04-20 |
30-day Notice |
| S024 |
2014-11-07 |
Real-time Process |
| S023 |
2014-04-30 |
Normal 180 Day Track No User Fee |
| S022 |
2014-03-03 |
Real-time Process |
| S021 |
2013-11-27 |
Normal 180 Day Track |
| S020 |
2013-08-30 |
30-day Notice |
| S019 |
2011-11-29 |
135 Review Track For 30-day Notice |
| S018 |
2011-10-14 |
30-day Notice |
| S017 |
2011-05-09 |
30-day Notice |
| S016 |
2011-01-18 |
30-day Notice |
| S015 |
2010-11-16 |
Real-time Process |
| S014 | | |
| S013 |
2010-02-22 |
30-day Notice |
| S012 |
2009-12-14 |
30-day Notice |
| S011 |
2009-07-30 |
30-day Notice |
| S010 |
2009-05-04 |
30-day Notice |
| S009 |
2008-11-10 |
30-day Notice |
| S008 |
2008-09-04 |
Normal 180 Day Track |
| S007 |
2008-05-14 |
30-day Notice |
| S006 |
2007-02-12 |
Real-time Process |
| S005 |
2006-12-18 |
135 Review Track For 30-day Notice |
| S004 |
2006-09-05 |
Normal 180 Day Track |
| S003 |
2006-06-12 |
Normal 180 Day Track |
| S002 |
2005-11-09 |
30-day Notice |
| S001 |
2005-04-01 |
Normal 180 Day Track |
NIH GUDID Devices