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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® EYEJET® CTR Single-Use Injector
Generic NameRing, endocapsular
ApplicantMorcher GmbH
Kapuzinerweg 12
Stuttgart D-70374
PMA NumberP010059
Supplement NumberS012
Date Received02/02/2024
Decision Date03/01/2024
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  
a change to the ink used for printing on the outside of the Tyvek packaging lid
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