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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 RINGS
Generic NameRing, endocapsular
ApplicantMORCHER GMBH
KAPUZINERWEG 12
STUTTGART, WURTTEMBERG-BADEN D-703-7037
PMA NumberP010059
Supplement NumberS003
Date Received03/19/2007
Decision Date05/22/2009
Product Code MRJ 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF CAPSULAR TENSION RINGS (CTRS) MODELS1G, 2S, 6D, 6E, AND 10C AND CHANGE IN PACKAGING TO INCORPORATE THE MORCHER INJECTOR PRELOADED WITH CTR MODELS 14, 14A, AND 14C. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MORCHER CAPSULAR TENSION RINGS (MODELS 1G, 2S, 6D, 6E, AND 10C) AND EYEJET CTR AND IS INDICATED FOR THE STABILIZATION OF THE CRYSTALLINE LENS CAPSULE IN THE PRESENCE OF WEAK ORPARTIALLY ABSENT ZONULES IN ADULT PATIENTS UNDERGOING CATARACT EXTRACTION WITH INTRAOCULAR LENSIMPLANTATION. CONDITIONS ASSOCIATED WITH WEAK OR PARTIALLY ABSENT ZONULES MAY INCLUDE PRIMARYZONULAR WEAKNESS (E.G., MARFAN'S SYNDROME), SECONDARY ZONULAR WEAKNESS (E.G., TRAUMA ORVITRECTOMY), CASES OF ZONULYSIS, CASES OF PSEUDOEXFOLIATION AND CASES OF MARCHESANI¿S SYNDROME.
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