Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: MODELS 1S & 1P
• Classification Name: intraocular lens
• Generic Name: iris fixation iol
• Regulation Number: 886.3600
• Applicant: CILCO, INC.
• PMA Number: P800049
• Supplement Number: S001
• Date Received: 07/12/1983
• Decision Date: 05/09/1985
• Product Code: HQL [ Registered Establishments with HQL ]
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No