|
Device | CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | IOLTECH, S.A. 64 SCHOOSETT STREET PENBROKE, MA 02359-1882 |
PMA Number | P960036 |
Supplement Number | S006 |
Date Received | 06/06/2002 |
Decision Date | 06/20/2002 |
Withdrawal Date
|
10/12/2006 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |