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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.
 
DeviceClareon Aspheric Hydrophobic Acrylic Intraocular Lens (with the AutonoMe Pre-Loaded Delivery System) Claeron Toric Asphe
Generic Nameintraocular lens
ApplicantAlcon Laboratories, LLC
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP190018
Supplement NumberS005
Date Received05/29/2020
Decision Date02/18/2021
Product Codes HQL MJP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a contract sterilization site located at Synergy Health Sterilisation UK Ltd., Unit 1, Alpha Court, Capitol Park, Thorne, Doncaster DN8 5TZ United Kingdom.
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