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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceHOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHoya Surgical Optics, Inc.
14768 Pipeline Ave.
Chino Hills, CA 91709
PMA NumberP080004
Date Received01/31/2008
Decision Date09/26/2008
Product Code HQL 
Docket Number 08M-0536
Notice Date 10/07/2008
Advisory Committee Ophthalmic
Clinical TrialsNCT00625313
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE HOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS. THE DEVICE IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S006 S008 S007 S013 S009 S017 S001 S005 S002 S016 S019 
S020 S023 S035 S036 S033 S034 S038 S039 S045 S042 S040 S021 
S018 S022 S024 S025 S047 S004 S011 S012 S010 S037 S026 S027 
S028 S029 S030 S031 S032 S041 S014 S043 S015 S046 
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