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: OPUS - III CONTACT LENSES
• Generic Name: Lens, contact (other material) - daily
• Regulation Number: 886.5916
• Applicant: Wesley Jessen Corp.; 333 E. Howard Ave.; Des Plaines, IL 60018
• PMA Number: P820074
• Supplement Number: S004
• Date Received: 07/27/1984
• Decision Date: 06/25/1985
• Product Code: HQD
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No