PMA P030023S004

Device: CAPSULAR TENSION RING AND STABILEYES
Applicant: Ophtec BV
PMA number: P030023
Supplement: S004
Product code: MRJ
Decision date: 2015-11-13
Classification: Ring, Endocapsular
Generic name: Ring, endocapsular
Approval order 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 SUSPECTED OR OBSERVED DURING CATARACT EXTRACTION USING PHACOEMULSIFICATION AND CONTINUOUS CURBILINEAR CAPSULORHEXIS TECHNIQUES IN ADULTS.

Current openFDA PMA Record#

Device: CAPSULAR TENSION RING AND STABILEYES
Applicant: Ophtec BV
PMA number: P030023
Supplement: S004
Product code: MRJ
Generic name: Ring, endocapsular
Decision date: 2015-11-13
Decision code: APPR
Date received: 2014-07-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order 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 SUSPECTED OR OBSERVED DURING CATARACT EXTRACTION USING PHACOEMULSIFICATION AND CONTINUOUS CURBILINEAR CAPSULORHEXIS TECHNIQUES IN ADULTS.