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. |
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Device | CT LUCIA Intraocular lens (Model 611P) |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Carl Zeiss Meditec Production LLC 1040 South Vintage Avenue, Bldg. A Ontario, CA 91761-3631 |
PMA Number | P100016 |
Supplement Number | S008 |
Date Received | 09/08/2020 |
Decision Date | 07/08/2021 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT03451786
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a new product model, CT LUCIA 611P, which is a design change to product CT LUCIA 602. |
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