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: ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
• Generic Name: Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
• Applicant: Nidek, Inc.; 47651 Westinghouse Dr.; Fremont, CA 94539
• PMA Number: P830062
• Supplement Number: S001
• Date Received: 07/12/1984
• Decision Date: 10/23/1984
• Withdrawal Date: 11/27/2013
• Product Code: LOI
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No