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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCLEAR-OPTIC AND ASPHERIC SURFACE INTRAOCULAR LENSES
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantHOYA SURGICAL OPTICS, INC.
PMA NumberP080004
Supplement NumberS004
Date Received01/22/2010
Decision Date04/04/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for clear-optic spheric and aspheric surface intraocular lenses (iols), models pc-60r, pc-60ad and fc-60ad.
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