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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.
 
DeviceiSert® Pre-loaded System; IPURE Pre-loaded System; PreVue Pre-loaded System
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantHoya Surgical Optics, Inc.
14768 Pipeline Ave.
Chino Hills, CA 91709
PMA NumberP080004
Supplement NumberS043
Date Received10/04/2021
Decision Date12/28/2021
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for nine (9) changes to the routine Ethylene Oxide (EO) sterilization process, including:1) The sterilization equipment used in your routine EO sterilization process;2) the implementation of a unified set of EO sterilization process parameters for your US marketed products;3) the lower control limit for EO gas used in your routine EO sterilization process;4) the method for monitoring EO gas concentration;5) the frequency of EO sterilant residuals testing; 6) the Process Challenge Device (PCD) used during routine EO sterilization cycles and validation activities;7) the number of PCDs used during routine EO sterilization cycles and validation activities;8) the approach used for validation/re-validation activities; and9) the re-validation cycle.
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