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: CIBA OPAQUE(TEFILICON)(HYDROPHILIC) CONTACT LENS
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Ciba Vision Care; 11460 Johns Creek Pkwy.; Duluth, GA 30136
• PMA Number: P810005
• Supplement Number: S027
• Date Received: 05/01/1991
• Decision Date: 12/10/1991
• APCB Date: 05/26/2009
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No