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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 NameACRYSOR SINGLE PIECE POSTERIOR CHAMBER INTRAOCULAR LENS MODEL SA60AT ECTEDED DIOPTER RANGE
Classification Nameintraocular lens
Generic Nameintraocular lenses
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP930014
Supplement NumberS010
Date Received09/11/2002
Decision Date10/07/2002
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the model sa60at power range from +6. 0d through +34. 0d to +6. 0 through +40. 0d.
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