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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 SINGLE-PIECE ANTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP880087
Supplement NumberS023
Date Received12/09/2015
Decision Date01/06/2016
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REQUESTED PARAMETRIC RELEASE FOR THE ALCON HUNTINGTON AODC NORTH (AODC-N) ETHYLENE OXIDE STERILIZATION PROCESS.
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