Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• 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
• Supplement Number: S001
• Date Received: 04/28/1987
• Decision Date: 08/28/1987
• Withdrawal Date: 08/08/2012
• Product Code: LWX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No