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 621P |
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 | S017 |
Date Received | 05/12/2023 |
Decision Date | 10/02/2023 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an extension of the shelf life for the subject CT LUCIA 621P intraocular lens (IOL) in BLUESERT injector from 18-months to 36-months. |
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