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: BIOMEDICS 38 (POLYMACON) UV BLOCKING CONTACT LENSES
• Generic Name: Lenses, soft contact, extended wear
• Applicant: CooperVision, Inc.; 370 Woodcliff Dr.; Suite 200; Fairport, NY 14450
• PMA Number: P780007
• Supplement Number: S043
• Date Received: 01/10/2003
• Decision Date: 09/12/2003
• Product Codes: LPL LPM
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Express GMP Supplement
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT OCULAR SCIENCES, ALBUQUERQUE, NEW MEXICO.