THE HEART LASER CO2 TMR SYSTEM
FDA premarket approval P950015/S001 · decided 1998-10-06
Approval details
- PMA number
- P950015
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- THE HEART LASER CO2 TMR SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 1998-09-21
- Decision date
- 1998-10-06
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- Approval for the post approval clinical study to be conducted as a condition of approval.
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