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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.
 
DeviceCT LUCIA 621P
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec Production LLC
1040 South Vintage Avenue, Bldg. A
Ontario, CA 91761-3631
PMA NumberP100016
Supplement NumberS009
Date Received08/23/2021
Decision Date02/07/2023
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new product model, CT LUCIA 621P, which is a design change to the currently approved product CT LUCIA 611P.
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