Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: Eyekon Medical, Inc.; 2451 Enterprise Rd.; Clearwater, FL 33763
• PMA Number: P880072
• Date Received: 10/07/1988
• Decision Date: 09/22/1989
• Product Code: HQL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No
• Supplements: S045 S037 S039 S040 S042 S044 S026 S027 S028 S029 S030 S032 ; S033 S034 S035 S036 S001 S003 S005 S007 S008 S010 S011 S012 ; S014 S015 S016 S018 S019 S021 S047