CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
FDA premarket approval P960036/S006 · decided 2002-06-20
Approval details
- PMA number
- P960036
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Ioltech, S.A.
- Date received
- 2002-06-06
- Decision date
- 2002-06-20
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Penbroke, MA
- 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.
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