TMR2000 HOLMIUM LASER SYSTEM
FDA premarket approval P970029/S011 · decided 2007-11-05
Approval details
- PMA number
- P970029
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- TMR2000 HOLMIUM LASER SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2007-05-09
- Decision date
- 2007-11-05
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL FOR PEARL 5.0 HANDPIECE.
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