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 | iSert Preloaded IOL System: iSert 250, iSert 251, iSert 230, iSert 231 & IPure™ Preloaded IOL System/ Model B1PC (Clear |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | HOYA SURGICAL OPTICS, INC. 14768 PIPELINE AVENUE CHINO HILLS, CA 91709 |
PMA Number | P080004 |
Supplement Number | S046 |
Date Received | 12/02/2022 |
Decision Date | 05/04/2023 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a reduction in the duration of the heated aeration phase of your existing approved Ethylene Oxide sterilization process. |
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