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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.
 
DeviceCapsular Tension Ring (CTR)
Generic NameRing, endocapsular
ApplicantOPHTEC BV
Schweitzerlaan 15
Groningen 9728
PMA NumberP030023
Supplement NumberS007
Date Received12/18/2018
Decision Date03/27/2019
Product Code MRJ 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Ethylene oxide sterilization cycle improvements for 1 full sterilization cycle for the Artisan Myopia Intraocular Lenses sterilized at AT Sterigenics in Belgium.
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