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Device | TMR HOLMIUM LASER SYSTEM |
Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. KENNESAW, GA 30144 |
PMA Number | P970029 |
Date Received | 07/02/1997 |
Decision Date | 02/11/1999 |
Product Code |
MNO |
Docket Number | 99M-2238 |
Notice Date | 07/19/1999 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement Approval for the Eclipse TMR Holmium Laser System. Transmyocardial revascularization with the Eclipse TMR System is indicated for treatment of stable patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium iwth reversible ischemia not amendable to direct coronary revascularization. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S003 S005 S006 S007 S008 S009 S011 S012 S013 S014 S015 S017 S018 S019 S020 S021 S022 S024 S025 S026 S027 S028 S029 S030 S032 S033 S034 S035 S036 S037 S038 S039 S040 |