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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 MULTIPEICE POSTERIOR CHAMBER LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES
6201 S FREEWAY
FT WORTH, TX 76134
PMA NumberP810032
Supplement NumberS061
Date Received05/29/2012
Decision Date06/21/2012
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE MONOFILAMENT DRAW LINE SYSTEM.
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