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: MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
• Classification Name: laser, neodymium:yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
• Applicant: CHIRON VISION CORP.
• PMA Number: P840012
• Supplement Number: S003
• Date Received: 04/01/1987
• Decision Date: 08/27/1987
• Product Code: LOI
• Docket Number: 87M-0305
• Notice Date: 10/19/1987
• Advisory Committee: Ophthalmic
• Supplement Type: panel track
• Supplement Reason: labeling change - indications
• Expedited Review Granted?: No
• Combination Product: No