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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.
 
DeviceMorcher Capsular Tension Ring
Generic NameRing, endocapsular
ApplicantMorcher GmbH
Kapuzinerweg 12
Stuttgart D-70374
PMA NumberP010059
Supplement NumberS008
Date Received05/30/2023
Decision Date11/04/2024
Product Code MRJ 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for change in supplier of the following critical components: Eyejet CTR Body, Push Button, Cartridge, Clamp and Rod
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