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: TORAY SOFT CONTACT LENSES
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Toray Industries (America), Inc.; 1-1-1 Sonoyama; Otsu-Shi, Shiga-Ken 520 520
• PMA Number: P840044
• Supplement Number: S002
• Date Received: 12/18/1989
• Decision Date: 02/01/1990
• Withdrawal Date: 10/10/2007
• Product Code: LPM
• 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