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: TRI POL
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Aquarius Soft Lens, Inc.; 1718 Lafayette Rd.; Indianapolis, IN 46222
• PMA Number: N18162
• Supplement Number: S001
• Date Received: 05/21/1979
• Decision Date: 06/07/1979
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No