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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePMMA ANTERIOR CHAMBER IOLS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ALCON LABORATORIES
6201 s freeway
ft worth, TX 76134
PMA NumberP880087
Supplement NumberS021
Date Received12/26/2012
Decision Date07/23/2013
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ALCON RESEARCH, LTD., IN LESAGE, WEST VIRGINIA.
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