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 602, CT Lucia 202, CT Lucia 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 | S012 |
Date Received | 03/03/2022 |
Decision Date | 03/25/2022 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of validated ethylene oxide sterilization Chamber #9 with its validated Cycle #834 to the routine sterilization process. |
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