THE HEART LASER(TM)CO2 TMR SYSTEM
FDA premarket approval P950015/S007 · decided 2000-09-27
Approval details
- PMA number
- P950015
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Trade name
- THE HEART LASER(TM)CO2 TMR SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 2000-09-12
- Decision date
- 2000-09-27
- Days to decision
- 15 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- APPROVAL TO MODIFY THE EXISTING POST-APPROVAL STUDY TO NO LONGER REQUIRE STUDY ENROLLMENT AT NEW SITES, AND TO LIMIT STUDY PARTICIPATION TO THOSE (EXISTING) SITES WHICH HAVE ENROLLED PATIENTS.
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