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: HYDRO MARC LENSES (HYDROPHILIC)
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Vistakon, Johnson & Johnson Vision Products, Inc.; 7500 Centurion Pkwy.; Jacksonville, FL 32256
• PMA Number: N18033
• Supplement Number: S009
• Date Received: 12/21/1983
• Decision Date: 03/29/1984
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No