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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.
 
DeviceSPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER
Classification Namedevice, angioplasty, laser, coronary
Generic Namedevice, angioplasty, laser, coronary
Applicant
TRIMEDYNE, INC.
25901 commercentre dr
lake forest, CA 92630
PMA NumberP870043
Supplement NumberS002
Date Received10/13/1988
Decision Date11/30/1989
Product Code
LPC[ Registered Establishments with LPC ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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