Artisan Myopia

FDA Premarket Approval P030028 S009

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceArtisan Myopia
Generic NameLens, Intraocular, Phakic
ApplicantOPHTEC BV6421 Congress Ave,suite 112boca Raton, FL 33487 PMA NumberP030028 Supplement NumberS009 Date Received02/08/2022 Decision Date07/22/2022 Product Code MTA  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-02-08
Decision Date2022-07-22
PMAP030028
SupplementS009
Product CodeMTA 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressOPHTEC BV
6421 Congress Ave,suite 112
boca Raton, FL 33487 PMA NumberP030028 Supplement NumberS009 Date Received02/08/2022 Decision Date07/22/2022 Product Code MTA  Advisory Committee Ophthalmic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Change To The Processing Agent Used In The Milling Process For The ARTISAN Myopia

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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