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: STYLES 31-34 POSTERIOR IOLS
• Generic Name: intraocular lens
• Regulation Number: 886.3600
• Applicant: CARL ZEISS MEDITEC AG; 5160 Hacienda Drive; Dublin, CA 94568
• PMA Number: P830056
• Date Received: 10/18/1983
• Decision Date: 03/28/1986
• Withdrawal Date: 10/12/2006
• Product Code: HQL
• Docket Number: 86M-0239
• Notice Date: 06/18/1986
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 ; S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 ; S025 S026 S027 S028 S029 S030 S031 S032 S033 S035 S036 S039 ; S040 S041 S042 S043 S044 S046 S047 S050 S055 S060 S061 S068 ; S069 S070 S071 S072 S074 S075 S077 S078 S079