TMR HOLMIUM LASER SYSTEM
FDA premarket approval P970029/S013 · decided 2008-12-30
Approval details
- PMA number
- P970029
- Supplement
- S013
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- TMR HOLMIUM LASER SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Cryolife, Inc.
- Date received
- 2008-10-22
- Decision date
- 2008-12-30
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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