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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.
Classification Nameintraocular lens
Generic Nameintraocular lenses (iol)21 cfr 886.3600/class iii
Regulation Number886.3600
PMA NumberP930014
Supplement NumberS076
Date Received12/16/2014
Decision Date03/10/2015
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the acrysof® aspheric uv absorbing intraocular lens (iol) model sa60wf. The device, as modified, will be marketed under the trade name acrysof® aspheric uv absorbing intraocular lenses (iols) and is indicated for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag.