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: INTRAOCULAR LENSES
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Eyekon Medical, Inc.; 2451 Enterprise Rd.; Clearwater, FL 33763
• PMA Number: P880072
• Supplement Number: S015
• Date Received: 05/15/1990
• Decision Date: 07/13/1990
• 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