OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US

Ring, Endocapsular

FDA Premarket Approval P030023

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the oculaid capsular tension ring (model 275 10/12 mm and model 276 11/13 mm), also known as the stableyes capsular tension ring (model 275 10/12 mm and model 276 11/13 mm), to be distributed by advanced medical optics. The device is indicated for the stabilization of weakened, broken or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults.

Device	OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
Classification Name	Ring, Endocapsular
Generic Name	Ring, Endocapsular
Applicant	OPHTEC USA, INC.
Date Received	2003-06-17
Decision Date	2004-04-27
Notice Date	2004-05-26
PMA	P030023
Supplement	S
Product Code	MRJ
Docket Number	04M-0248
Advisory Committee	Ophthalmic
Expedited Review	No
Combination Product	No
Applicant Address	OPHTEC USA, INC. 6421 Congress Ave., Suite 112 boca Raton, FL 33487
Summary:	Summary of Safety and Effectiveness
Labeling:	Labeling
Approval Order:	Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P030023		Original Filing
S008	2022-02-08	30-day Notice
S007	2018-12-18	30-day Notice
S006
S005	2016-06-10	30-day Notice
S004	2014-07-21	Normal 180 Day Track
S003
S002	2012-01-05	135 Review Track For 30-day Notice
S001	2011-10-19	Normal 180 Day Track No User Fee

NIH GUDID Devices

Device ID	PMA	Supp
08717819070286	P030023	004
08717819070279	P030023	004