THE HEART LASER CO2 TMR SYSTEM
FDA premarket approval P950015/S011 · decided 2009-03-08
Approval details
- PMA number
- P950015
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- THE HEART LASER CO2 TMR SYSTEM
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 2008-09-12
- Decision date
- 2009-03-08
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- APPROVAL FOR CHANGES MADE TO THE LABELING AS A RESULT OF COMPLETION OF THE POST-APPROVAL STUDY.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.