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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.
 
DeviceACRYSOF INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy. Dr.
Fort Worth, TX 76134
PMA NumberP930014
Supplement NumberS083
Date Received07/27/2015
Decision Date08/26/2015
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  
CHANGE TO A NEW MEASUREMENT SYSTEM FOR QUALITY CONTROL INSPECTION OF OPTICAL PERFORMANCE OF YOUR ACRYSOF® MONOFOCAL IOLS (P930014) (MODELS SN60WF, SN6CWS, SA60WF, SA60AT, SN60AT, TYPE 7B, MA30AC, MN60AC, MA60AC, US60MP, MN60MA, AND MA60MA).
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