AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS
FDA premarket approval P100016/S001 · decided 2013-05-28
Approval details
- PMA number
- P100016
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS
- Generic name
- intraocular lens
- Applicant
- Carl Zeiss Meditec Production, LLC
- Date received
- 2013-02-19
- Decision date
- 2013-05-28
- Days to decision
- 98 days
- Decision code
- APPR
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Ontario, CA
- Statement
- APPROVAL FOR A CHANGE TO THE TRADE NAME OF THE APPROVED LENSES AND LABELING CHANGES TO THE UNIT CARTON, INCLUDING A CHANGE TO THE COLOR SCHEME AND FORMAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AARIS ACRYLIC INTRAOCULAR LENS (IOL), MODELS EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.
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