Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: TRIMEDYNE'S LASERPROBE-PLR{TM} CATHETER & OPTILASE
• Generic Name: Device. Laser peripheral angioplasty
• Applicant: TRIMEDYNE, INC.; 25901 COMMERCENTRE DR; LAKE FOREST, CA 92630
• PMA Number: P860042
• Date Received: 09/02/1986
• Decision Date: 02/27/1987
• 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