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: MODELS B-13F (P-10) & B-1H (P-11)
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Alcon Laboratories; 6201 S. Fwy.; Fort Worth, TX 76134
• PMA Number: P810032
• Supplement Number: S013
• Date Received: 05/18/1987
• Decision Date: 05/03/1988
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Other
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No