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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSPECTRAPROBE-PLR MODEL 900 OPTILASE CONTACT LASER
Classification Namedevice, angioplasty, laser, coronary
Generic Nameargon laser for peripheral reconalizaton
ApplicantTRIMEDYNE, INC.
PMA NumberP870043
Date Received07/29/1987
Decision Date06/30/1988
Withdrawal Date 08/08/2012
Product Code
LPC[ Registered Establishments with LPC ]
Docket Number 88M-0264
Notice Date 08/10/1988
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S013 
S014 S015 S016 
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