CAPSULAR TENSION RING AND STABILEYES

FDA premarket approval P030023/S004 · decided 2015-11-13

Approval details

PMA number

P030023

Supplement

S004

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

CAPSULAR TENSION RING AND STABILEYES

Generic name

Ring, endocapsular

Applicant

Ophtec BV

Date received

2014-07-21

Decision date

2015-11-13

Days to decision

480 days

Decision code

APPR

Product code

MRJ

Advisory committee

Ophthalmic

Expedited review

No

Location

Groningen

Statement

APPROVAL TO INCLUDE THE RINGJECT, A DISPOSABLE INJECTOR/DELIVERY SYSTEM DESIGNED FOR USE WITH CAPSULAR TENSION RINGS (CTRS), ADDITION OF THE INJECTOR INTO THE SAME STERILE PACKAGING PROCESS AS THE CTR AND MODIFICATION OF THE PACKAGING CONFIGURATION TO ACCOMMODATE THE COMBINED INJECTOR AND THE PRELOADED CTR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RINGJECT, MODEL 375 AND MODEL 376. CTRS ARE INDICATED FOR THE STABILIZATION OF WEAKENED, BROKEN, OR MISSING ZONULES THAT ARE SUS