HEART LASER 2 (HL2)
FDA premarket approval P950015/S008 · decided 2001-01-29
Approval details
- PMA number
- P950015
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEART LASER 2 (HL2)
- Generic name
- SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION
- Applicant
- Laser Engineering Heart, Inc.
- Date received
- 2000-09-28
- Decision date
- 2001-01-29
- Days to decision
- 123 days
- Decision code
- APPR
- Product code
- MNO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Nashville, TN
- Statement
- APPROVAL FOR A MANUFACTURING CHANGE TO UP-DATE THE LASER CONSOLE PORTION OF THE DEVICE SYSTEM FROM THE CURRENTLY APPROVED HL1 (HEART LASER(TM)) TO THE HL2 (HEAR LASER 2). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HEART LASER 2 (HL2), AND IS INDICATED FOR USE IN THE TREATMENT OF PATIENTS WITH STABLE ANGINA (CANADIAN CARDIOVASCULAR SOCIETY CLASS 3 OR 4) REFRACTORY TO MEDICAL TREATMENT AND SECONDARY TO OBJECTIVELY DEMONSTRATED CORONARY ARTERY ATHEROSCLEROSIS AND WITH A REGION O
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