Implement non-product software changes to the ampere generator and remote control calibration and functional tests, and the best electrical automated safety tester (beast) electrical test processes involved in the manufacture of ampere generator and remote control.
| Device | Ampere™ Generator |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | IRVINE BIOMEDICAL, INC. |
| Date Received | 2021-09-14 |
| Decision Date | 2021-10-14 |
| PMA | P040014 |
| Supplement | S045 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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