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: MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
• Generic Name: Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
• Applicant: Meridian AG; Bierigutstrauss 7; Ch-3608; Thun, Be
• PMA Number: P840012
• Supplement Number: S003
• Date Received: 04/01/1987
• Decision Date: 08/27/1987
• Withdrawal Date: 09/15/2011
• Product Code: LOI
• Docket Number: 87M-0305
• Notice Date: 10/19/1987
• Advisory Committee: Ophthalmic
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No