THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER)
FDA premarket approval P950015/S005 · decided 2000-03-08
Approval details
- PMA number
- P950015
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE HEART LASER-TM CO2 TMR SYSTEM (THE HEART LASER)
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 1999-06-28
- Decision date
- 2000-03-08
- Days to decision
- 254 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- Approval for specific software revisions addressed to disarming the laser after it has fired and to resolving a minor Y2K problem.
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