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: ISTAMARC TORIC (ETAFILCONA))
• 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: S017
• Date Received: 09/16/1987
• Decision Date: 10/05/1987
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No