THE HEART LASER CO2 TMR SYSTEM
FDA premarket approval P950015/S002 · decided 1999-04-27
Approval details
- PMA number
- P950015
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- THE HEART LASER CO2 TMR SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 1999-03-29
- Decision date
- 1999-04-27
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- Approval for changes to the labeling.
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