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: V-X (POLYMACON) ASPHERIC SOFT(HYDROPHILIC) LENSES
• Generic Name: Lenses, soft contact, daily wear
• Regulation Number: 886.5925
• Applicant: Gbf Contact Lenses, Inc.; 4217 Virginia Beach Blvd.; Virginia Beach, VA 23452
• PMA Number: P780013
• Supplement Number: S006
• Date Received: 07/22/1991
• Decision Date: 08/13/1991
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No