Capsular Tension Ring (CTR)

Ring, Endocapsular

FDA Premarket Approval P030023 S007

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

Ethylene oxide sterilization cycle improvements for 1 full sterilization cycle for the artisan myopia intraocular lenses sterilized at at sterigenics in belgium

• Device: Capsular Tension Ring (CTR)
• Classification Name: Ring, Endocapsular
• Generic Name: Ring, Endocapsular
• Applicant: OPHTEC USA, INC.
• Date Received: 2018-12-18
• Decision Date: 2019-03-27
• PMA: P030023
• Supplement: S007
• Product Code: MRJ
• Advisory Committee: Ophthalmic
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• 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