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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
Regulation Number886.3600
PMA NumberP930014
Supplement NumberS012
Date Received08/05/2003
Decision Date09/02/2003
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the package insert to create a new warning by moving and strengthening existing text within the approved insert to read as follows: "the clinical study of the acrysof natural single-piece lens (referenced in tables 2 through 5) was conducted with the lens intended for implantation in the capsular bag only. There is no clinical data to demonstrate its safety and effectiveness for placement in the ciliary sulcus. ".