CIONNI CAPSULAR TENSION RINGS

FDA Premarket Approval P010059 S002

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.

Pre-market Approval Supplement Details

Approval for the morcher cionni capsular tension rings (types 1l, 2l, and 2c). The device is indicated for the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation. Conditions associated with weak or partially absent zonules may include primary zonular weakness (e. G. , marfan's syndrome), secondary zonular weakness (e. G. , trauma or vitrectomy), cases of zonulysis, cases of pseudoexfoliation and cases of marchesani's syndrom.

DeviceCIONNI CAPSULAR TENSION RINGS
Generic NameRing, Endocapsular
ApplicantMORCHER GMBH
Date Received2004-08-03
Decision Date2005-10-14
PMAP010059
SupplementS002
Product CodeMRJ 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MORCHER GMBH kapuzinerweg 12 stuttgart, Wurttemberg-baden D-703-7037

Supplemental Filings

Supplement NumberDateSupplement Type
P010059Original Filing
S006 2016-08-02 Normal 180 Day Track No User Fee
S005
S004 2011-11-08 Normal 180 Day Track
S003 2007-03-19 Real-time Process
S002 2004-08-03 Normal 180 Day Track
S001 2004-01-20 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
04048509620004 P010059 007

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