PMA P030023S001

Device: OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
Applicant: Ophtec BV
PMA number: P030023
Supplement: S001
Product code: MRJ
Decision date: 2011-12-14
Classification: Ring, Endocapsular
Generic name: Ring, endocapsular
Approval order statement: 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.

Current openFDA PMA Record#

Device: OPHTEC CAPSULAR TENSION RING MODELS 276 AND 275 AND STABILEYES MODELS STBL2US AND STBL13US
Applicant: Ophtec BV
PMA number: P030023
Supplement: S001
Product code: MRJ
Generic name: Ring, endocapsular
Decision date: 2011-12-14
Decision code: APPR
Date received: 2011-10-19
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: 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.