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: OPTACRYL II BLUE
• Generic Name: Lens, contact (other material) - daily
• Regulation Number: 886.5916
• Applicant: Paragon Vision Sciences; 947 E. Impala Ave.; Mesa, AZ 85204
• PMA Number: P820056
• Supplement Number: S010
• Date Received: 08/19/1985
• Decision Date: 12/06/1985
• Product Code: HQD
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No