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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.
 
DeviceRINGJECT
Generic NameRing, endocapsular
ApplicantOphtec BV
Schweitzerlaan 15
Groningen 9728 NR
PMA NumberP030023
Supplement NumberS005
Date Received06/10/2016
Decision Date07/06/2016
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  
Modification of the current blunt finish distal tip on capsular tension ring (CTR) injector to an angular (beveled) distal tip finish.
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