THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
FDA premarket approval P950015 · decided 1998-08-20
Approval details
- PMA number
- P950015
- Trade name
- THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 1995-04-18
- Decision date
- 1998-08-20
- Days to decision
- 1220 days
- Decision code
- APWD
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Nashville, TN
- Statement
- Approval for The Heart Laser CO2 TMR System. This device is indicated for the treatment of patients with stable angina (Canadian Cardiovascular Society class 3 or 4) refractory to medical treatment and secondary to objectively demonstarted coronary artery atherosclerosis not amenable to direct coronary revascularization.
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