Product code MNO
- Device name
- System, Laser, Transmyocardial Revascularization
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P970029S040 | CardioGenesis TMR System | Cryolife, Inc. | 2022-09-01 |
| P970029S038 | TMR Holmium Laser System | Cryolife, Inc. | 2021-01-21 |
| P970029S039 | TMR Holmium Laser System | Cryolife, Inc. | 2019-05-02 |
| P970029S037 | TMR Holmium Laser System | Cryolife, Inc. | 2018-07-10 |
| P970029S036 | TMR Holmium Laser System | Cryolife, Inc. | 2017-09-08 |
| P970029S034 | TMR Holmium Laser System | Cryolife, Inc. | 2017-08-31 |
| P970029S033 | CardioGenesis TMR System | Cryolife, Inc. | 2017-08-07 |
| P970029S035 | TMR Holmium Laser System | Cryolife, Inc. | 2017-07-28 |
| P970029S032 | CARDIOGENESIS TMR LASER SYSTEM | Cryolife, Inc. | 2016-08-23 |
| P970029S030 | TMR HOLMIUM LASER SYSTEM | Cryolife, Inc. | 2016-06-23 |
| P970029S029 | TMR HOLMIUM LASER SYSTEM | Cryolife, Inc. | 2016-06-21 |
| P970029S028 | CARDIOGENESIS TMR SYSTEM | Cryolife, Inc. | 2015-12-22 |
| P970029S027 | PEARL 8.0 HANDPIECE | Cryolife, Inc. | 2015-04-03 |
| P950015S012 | HEART LASER CO2 TMR SYSTEM | Laser Engineering Heart, Inc. | 2014-07-23 |
| P970029S026 | CARDIOGENESIS TMR SYSTEM | Cryolife, Inc. | 2014-05-07 |
| P970029S025 | PEARL 8.0 HANDPIECE | Cryolife, Inc. | 2014-01-28 |
| P970029S024 | CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM | Cryolife, Inc. | 2013-05-31 |
| P970029S022 | PEARL 8.0 HANDPIECE FOR TRANSMYOCARDIAL REVASCULARIZATION (TMR) WITH THE CARDIOGENESIS HOLMIUM: YAG LASER SYSTEM | Cryolife, Inc. | 2012-12-18 |
| P970029S021 | CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM | Cryolife, Inc. | 2012-09-13 |
| P970029S020 | CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM | Cryolife, Inc. | 2012-07-26 |
| P970029S019 | TMR2000 HOLMIUM LASER SYSTEM | Cryolife, Inc. | 2012-05-25 |
| P970029S014 | CARDIOGENESIS HOLMIUM TMR SYSTEM | Cryolife, Inc. | 2012-02-22 |
| P970029S018 | CARDIOGENESIS TMR SYSTEM | Cryolife, Inc. | 2011-12-16 |
| P970029S017 | CARDIOGENESIS TMR 2000 HOLMIUM LASER SYSTEM | Cryolife, Inc. | 2010-04-15 |
| P970029S015 | CARDIOGENESIS TMR SYSTEM | Cryolife, Inc. | 2009-10-20 |
| P950015S011 | THE HEART LASER CO2 TMR SYSTEM | Laser Engineering Heart, Inc. | 2009-03-08 |
| P970029S013 | TMR HOLMIUM LASER SYSTEM | Cryolife, Inc. | 2008-12-30 |
| P970029S012 | SOLARGEN 2100S LASER | Cryolife, Inc. | 2008-09-11 |
| P970029S011 | TMR2000 HOLMIUM LASER SYSTEM | Cryolife, Inc. | 2007-11-05 |
| P950015S010 | THE HEART LASER CO2 TMR SYSTEM | Laser Engineering Heart, Inc. | 2005-03-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04048551425695 | n.a. | Karl Storz GmbH & Co. KG | 2024-12-20 |
| 00877234000096 | CardioGenesis | Artivion, Inc. | 2016-12-12 |
| 00877234000102 | CardioGenesis | Artivion, Inc. | 2016-12-12 |
| 00877234000119 | CardioGenesis | Artivion, Inc. | 2016-12-12 |
| 00860701000101 | The Heart Laser Disposable TMR kit | Novadaq Technologies Inc | 2014-09-17 |