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: CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Bausch & Lomb, Inc.; 1400 N. Goodman St.; Rochester, NY 14609
• PMA Number: P820072
• Supplement Number: S005
• Date Received: 03/29/1985
• Decision Date: 10/09/1985
• Withdrawal Date: 04/06/2009
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No