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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 (275,276); RingJect (375,376)
Generic NameRing, endocapsular
ApplicantOphtec BV
Schweitzerlaan 15
Groningen 9728 NR
PMA NumberP030023
Supplement NumberS012
Date Received08/27/2025
Decision Date10/06/2025
Product Code MRJ 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
addition of an alternative subcontractor for bioburden and endotoxin testing
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