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: CHAMBER LENS MODELS 101, 101B, 101T
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Bausch & Lomb; 1400 N. Goodman St.; Rochester, NY 14609
• PMA Number: P790027
• Supplement Number: S021
• Date Received: 11/12/1985
• Decision Date: 06/05/1986
• Withdrawal Date: 11/26/2008
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No