THE HEART LASER CO2 TMR SYSTEM
FDA premarket approval P950015/S010 · decided 2005-03-21
Approval details
- PMA number
- P950015
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE HEART LASER CO2 TMR SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 2004-07-06
- Decision date
- 2005-03-21
- Days to decision
- 258 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE ELECTRONIC PRE-IGNITION SYSTEM USED BY THE LASER MEDICAL DEVICE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.