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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 NameISERT MODEL PC-60AD PACKAGING IMPROVEMENT
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantHOYA SURGICAL OPTICS, INC.
PMA NumberP080004
Supplement NumberS012
Date Received05/29/2012
Decision Date07/17/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a packaging configuration change for the isert model pc-60ad intraocular lens (iol). The device, as modified, will be marketed under the trade name isert model 230 and 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.
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