Approval for changes to thermal and egm boards, upgrade to the firmware and software, addition of remote control fiber cord lengths and updates to the instruction for use of the ampere generator.
| Device | THERAPY CATHETER (NON-IRRIGATED) |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | IRVINE BIOMEDICAL, INC. |
| Date Received | 2014-03-03 |
| Decision Date | 2014-04-28 |
| PMA | P040014 |
| Supplement | S022 |
| 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