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 COOL PATH, SAFIRE BLU, SAFIRE BLU SP AND THERAPY COOL PATH SP ABLATION CATHETERS, AND 1500T9-CP RF GENERATORS |
| 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 | P060019 |
| Supplement | S035 |
| Product Code | LPB |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 |
|---|
| P060019 | | Original Filing |
| S054 |
2021-09-14 |
30-day Notice |
| S053 |
2021-04-19 |
30-day Notice |
| S052 |
2021-04-13 |
30-day Notice |
| S051 |
2021-02-25 |
30-day Notice |
| S050 |
2021-01-13 |
Real-time Process |
| S049 |
2020-09-18 |
30-day Notice |
| S048 | | |
| S047 |
2020-02-20 |
Real-time Process |
| S046 |
2020-02-04 |
30-day Notice |
| S045 |
2019-03-15 |
30-day Notice |
| S044 |
2018-12-12 |
Special (immediate Track) |
| S043 | | |
| S042 |
2018-02-05 |
30-day Notice |
| S041 |
2017-09-11 |
Real-time Process |
| S040 | | |
| S039 |
2017-05-04 |
30-day Notice |
| S038 |
2016-08-12 |
30-day Notice |
| S037 |
2016-05-27 |
30-day Notice |
| S036 |
2016-02-19 |
30-day Notice |
| S035 |
2015-11-20 |
Real-time Process |
| S034 |
2015-09-23 |
30-day Notice |
| S033 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S032 |
2015-05-15 |
Normal 180 Day Track No User Fee |
| S031 |
2015-04-20 |
30-day Notice |
| S030 |
2014-11-07 |
Real-time Process |
| S029 |
2014-09-09 |
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 |
2013-09-25 |
Normal 180 Day Track |
| S024 |
2013-08-30 |
30-day Notice |
| S023 |
2012-07-11 |
135 Review Track For 30-day Notice |
| S022 |
2012-07-10 |
Real-time Process |
| S021 |
2012-05-11 |
Real-time Process |
| S020 |
2011-11-29 |
135 Review Track For 30-day Notice |
| S019 |
2011-10-14 |
30-day Notice |
| S018 | | |
| S017 |
2011-01-18 |
30-day Notice |
| S016 |
2010-11-30 |
30-day Notice |
| S015 |
2010-11-16 |
Real-time Process |
| S014 |
2010-09-29 |
30-day Notice |
| S013 |
2010-08-30 |
Normal 180 Day Track |
| S012 | | |
| S011 |
2010-02-22 |
30-day Notice |
| S010 |
2009-12-14 |
30-day Notice |
| S009 |
2009-05-14 |
Normal 180 Day Track |
| S008 |
2009-05-04 |
30-day Notice |
| S007 |
2008-11-10 |
30-day Notice |
| S006 | | |
| S005 |
2008-07-14 |
Normal 180 Day Track |
| S004 |
2008-04-14 |
Real-time Process |
| S003 |
2007-06-07 |
Real-time Process |
| S002 |
2007-05-31 |
Real-time Process |
| S001 |
2007-03-30 |
135 Review Track For 30-day Notice |
NIH GUDID Devices