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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
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
HOYA SURGICAL OPTICS, INC.
14768 pipeline avenue
chino hills, CA 91709
PMA NumberP080004
Date Received01/31/2008
Decision Date09/26/2008
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 08M-0536
Notice Date 10/07/2008
Advisory Committee Ophthalmic
Clinical Trials NCT00625313
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 
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