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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 Nameposterior chamber intraocular lens
Regulation Number886.3600
PMA NumberP810055
Supplement NumberS068
Date Received05/14/1997
Decision Date10/22/1997
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 dioptric power range of model 812b to -10d to +40d. The device is indicated for use in the visual correction of aphakia in patients 60 years of age and older, who are undergoing a primary lens implantation, in either the ciliary sulcus or capsular bag following an extracapsular cataract extraction.