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: EYERISOL(R)
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Bionomics Intl., Inc.; 7803 Somerset Blvd.; Paramount, CA 90723
• PMA Number: P810034
• Supplement Number: S002
• Date Received: 11/04/1983
• Decision Date: 05/28/1985
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No