Premarket Approval (PMA)

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.

• Trade Name: SPECTRAPROBE-PLR CATH. & OPTILASE/CARDIOLASE LASER
• Classification Name: device, angioplasty, laser, coronary
• Generic Name: peripheral laser reconalization system
• Applicant: TRIMEDYNE, INC.
• PMA Number: P870043
• Supplement Number: S014
• Date Received: 04/23/1991
• Decision Date: 01/29/1992
• Product Code: LPC [ Registered Establishments with LPC ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No