HEART LASER(TM) CO2 TMR SYSTEM
FDA premarket approval P950015/S006 · decided 2000-01-11
Approval details
- PMA number
- P950015
- Supplement
- S006
- Supplement type
- Special (Immediate Track)
- Trade name
- HEART LASER(TM) CO2 TMR SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 1999-11-24
- Decision date
- 2000-01-11
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- SUPPLEMENTARY PRODUCT LABELING
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