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: COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: CooperVision, Inc.; 200 Willowbrook Office Park; Fairport, NY 14450
• PMA Number: P810057
• Supplement Number: S003
• Date Received: 03/30/1988
• Decision Date: 08/11/1988
• 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