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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameHEART LASER 2 (HL2)
Classification Namesystem, laser, transmyocardial revascularization
Generic Nametransmyocardial revascularization (tmr) device
ApplicantPLC MEDICAL SYSTEMS, INC.
PMA NumberP950015
Supplement NumberS008
Date Received09/28/2000
Decision Date01/29/2001
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order 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 of the myocardium not amenable to direct coronary revascularization.
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