ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)

Lens, Intraocular, Phakic

FDA Premarket Approval P030028

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the artisan (model 206 and 204) phakic intraocular lens, also known as the verisyse (vrsm5us and vrsm6us) phakic intraocular lens to be distributed by advance medical optics. The device is indicated for: 1) the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2. 5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3. 2 millimeters; and, 2) patients with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0. 50 diopters.

DeviceARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)
Classification NameLens, Intraocular, Phakic
Generic NameLens, Intraocular, Phakic
ApplicantOPHTEC BV
Date Received2003-07-01
Decision Date2004-09-10
Notice Date2005-01-21
PMAP030028
SupplementS
Product CodeMTA
Docket Number05M-0026
Advisory CommitteeOphthalmic
Expedited ReviewYes
Combination Product No
Applicant Address OPHTEC BV 6421 Congress Ave,suite 112 boca Raton, FL 33487
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P030028Original Filing
S009 2022-02-08 30-day Notice
S008 2019-02-06 Real-time Process
S007
S006 2018-09-18 30-day Notice
S005 2017-01-23 Normal 180 Day Track No User Fee
S004 2017-01-31 Normal 180 Day Track No User Fee
S003 2012-01-05 30-day Notice
S002 2010-10-29 30-day Notice
S001 2009-11-25 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
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08717819060126 P030028 001

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