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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.
 
DeviceFortiEYE CAPSULAR TENSION RINGS, TYPES 14, 14A AND 14C
Generic NameRing, endocapsular
ApplicantMorcher GmbH
Kapuzinerweg 12
Stuttgart D-70374
PMA NumberP010059
Supplement NumberS006
Date Received08/02/2016
Decision Date01/26/2017
Product Code MRJ 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for new private labeling for an alternative distributor.
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