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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 NameTRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
Classification Namedevice. laser peripheral angioplasty
Generic Nameargon laser fiberoptic thermal probe & laser sys
ApplicantTRIMEDYNE, INC.
PMA NumberP860042
Date Received09/02/1986
Decision Date02/27/1987
Withdrawal Date 08/08/2012
Product Code
LWX
Docket Number 87M-0076
Notice Date 04/06/1987
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S019 
S020 S021 S022 S023 S024 S025 S026 S027 
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