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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEC-3 INTRAOCULAR LENS (IOL) AND EC-3 PRECISION ASPHERIC LENS (PAL) IOL
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantAAREN SCIENTIFIC INC
PMA NumberP100016
Date Received04/22/2010
Decision Date10/19/2010
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 10M-0556
Notice Date 11/17/2010
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the ec-3 intraocular lens (iol) and ec-3 precision aspheric lens (pal) iol. The device 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.
Approval Order Approval Order
Supplements: S001 
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