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

Ring, Endocapsular

FDA Premarket Approval P030023 S001

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 a trade name change. The device, as modified, will be marketed under the trade name ophtec capsular tension ring models 276 and 275 and 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: 2011-10-19
• Decision Date: 2011-12-14
• PMA: P030023
• Supplement: S001
• Product Code: MRJ
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: OPHTEC USA, INC. 6421 Congress Ave., Suite 112 boca Raton, FL 33487

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