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: MICRO YAG ND:YAG LASER SYSTEM
• Generic Name: Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
• Applicant: Sorin Group USA, Inc.; 14401 W. 65th Way; Arvada, CO 80004
• PMA Number: P850063
• Supplement Number: S001
• Date Received: 05/19/1986
• Decision Date: 06/17/1986
• Withdrawal Date: 05/25/2011
• Product Code: LOI
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No