SOLARGEN 2100S LASER
FDA premarket approval P970029/S009 · decided 2004-12-23
Approval details
- PMA number
- P970029
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SOLARGEN 2100S LASER
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2004-03-24
- Decision date
- 2004-12-23
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR THE SOLARGEN 2100S LASER TO REPLACE THE TMR2000 LASER IN THE CARDIOGENESIS TMR HOLMIUM LASER SYSTEM. THE SOLARGEN 2100S WILL BE MANUFACTURED BY NEW STAR LASERS, INC. OF ROSEVILLE, CALIFORNIA.
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