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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameHOYA ISPHERIC MODEL YA-60BB INTRAOCULAR LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantHOYA SURGICAL OPTICS, INC.
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 
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