PMA P960036S006

Device: CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
Applicant: Ioltech, S.A.
PMA number: P960036
Supplement: S006
Product code: HQL
Decision date: 2002-06-20
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR A TRADE NAME CHANGE OF THE MEMORYLENS IOL. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE OF OLDER WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY AN EXTRACAPSULAR CATARACT EXTRACTION METHOD. THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.

Current openFDA PMA Record#

Device: CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
Applicant: Ioltech, S.A.
PMA number: P960036
Supplement: S006
Product code: HQL
Generic name: intraocular lens
Decision date: 2002-06-20
Decision code: APPR
Date received: 2002-06-06
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A TRADE NAME CHANGE OF THE MEMORYLENS IOL. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS AND IS INDICATED FOR PRIMARY IMPLANTATION FOR THE VISUAL CORRECTION OF APHAKIA IN PATIENTS 60 YEARS OF AGE OF OLDER WHERE A CATARACTOUS LENS HAS BEEN REMOVED BY AN EXTRACAPSULAR CATARACT EXTRACTION METHOD. THE LENS IS INTENDED FOR PLACEMENT IN THE CAPSULAR BAG.