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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) and RingJect
Generic NameRing, endocapsular
ApplicantOphtec BV
Schweitzerlaan 15
Groningen 9728 NR
PMA NumberP030023
Supplement NumberS009
Date Received03/30/2022
Decision Date08/01/2024
Product Code MRJ 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Sterigenics Germany GmbH, FEI 3006003617, Kasteler Str. 45 Wiesbaden Hesse, 65203, Germany, for Ethylene Oxide Sterilization of Capsular Tension Ring (CTS) and RingJect.
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