PMA P950015S007
- Device
- THE HEART LASER(TM)CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S007
- Product code
- MNO
- Decision date
- 2000-09-27
- Classification
- System, Laser, Transmyocardial Revascularization
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Approval order 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.
Current openFDA PMA Record#
- Device
- THE HEART LASER(TM)CO2 TMR SYSTEM
- Applicant
- Laser Engineering Heart, Inc.
- PMA number
- P950015
- Supplement
- S007
- Product code
- MNO
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Decision date
- 2000-09-27
- Decision code
- APPR
- Date received
- 2000-09-12
- Supplement type
- Real-Time Process
- Supplement reason
- Postapproval Study Protocol
- Approval order 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.