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: PREFERRED PLUS 53 SOFT (HYDROPHILIC) ASPHERIC LENS
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Ocu-Ease Optical Products, Inc.; 629 Tennent Ave.; Pinole, CA 94564
• PMA Number: P820051
• Supplement Number: S015
• Date Received: 02/18/1992
• Decision Date: 02/26/1993
• 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