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: PERMALENS EXTENDED WEAR CONTACT LENS
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: CooperVision, Inc.; 6150 Stoneridge Mall Rd.; Suite 500; Pleasanton, CA 94588
• PMA Number: P780010
• Supplement Number: S011
• Date Received: 05/16/1983
• Decision Date: 07/05/1983
• Withdrawal Date: 06/11/2014
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No