ARTISAN MYOPIA PHAKIC IOL

Lens, Intraocular, Phakic

FDA Premarket Approval P030028 S002

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

Shortening of ethylene oxide degassing phase process and the addition of an additional sterilization configuration.

DeviceARTISAN MYOPIA PHAKIC IOL
Classification NameLens, Intraocular, Phakic
Generic NameLens, Intraocular, Phakic
ApplicantOPHTEC BV
Date Received2010-10-29
Decision Date2010-11-23
PMAP030028
SupplementS002
Product CodeMTA
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address OPHTEC BV 6421 Congress Ave,suite 112 boca Raton, FL 33487

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
08717819048131 P030028 001
08717819047998 P030028 001
08717819047981 P030028 001
08717819047974 P030028 001
08717819047967 P030028 001
08717819047950 P030028 001
08717819047943 P030028 001
08717819047936 P030028 001
08717819047929 P030028 001
08717819047615 P030028 001
08717819047608 P030028 001
08717819047592 P030028 001
08717819048001 P030028 001
08717819048018 P030028 001
08717819048124 P030028 001
08717819048117 P030028 001
08717819048100 P030028 001
08717819048094 P030028 001
08717819048087 P030028 001
08717819048070 P030028 001
08717819048063 P030028 001
08717819048056 P030028 001
08717819048049 P030028 001
08717819048032 P030028 001
08717819048025 P030028 001
08717819047585 P030028 001
08717819047578 P030028 001
08717819047561 P030028 001
08717819047424 P030028 001
08717819047417 P030028 001
08717819047400 P030028 001
08717819047394 P030028 001
08717819047387 P030028 001
08717819047370 P030028 001
08717819047363 P030028 001
08717819047356 P030028 001
08717819047349 P030028 001
08717819047332 P030028 001
08717819047325 P030028 001
08717819047431 P030028 001
08717819047448 P030028 001
08717819047554 P030028 001
08717819047547 P030028 001
08717819047530 P030028 001
08717819047523 P030028 001
08717819047516 P030028 001
08717819047509 P030028 001
08717819047493 P030028 001
08717819047486 P030028 001
08717819047479 P030028 001
08717819047462 P030028 001
08717819047455 P030028 001
08717819047318 P030028 001
08717819070323 P030028 001
08717819060508 P030028 001
08717819060492 P030028 001
08717819060485 P030028 001
08717819060478 P030028 001
08717819060461 P030028 001
08717819060454 P030028 001
08717819060447 P030028 001
08717819060430 P030028 001
08717819060423 P030028 001
08717819060416 P030028 001
08717819060409 P030028 001
08717819060515 P030028 001
08717819060522 P030028 001
08717819060638 P030028 001
08717819060621 P030028 001
08717819060614 P030028 001
08717819060607 P030028 001
08717819060591 P030028 001
08717819060584 P030028 001
08717819060577 P030028 001
08717819060560 P030028 001
08717819060553 P030028 001
08717819060546 P030028 001
08717819060539 P030028 001
08717819060393 P030028 001
08717819060386 P030028 001
08717819060379 P030028 001
08717819060232 P030028 001
08717819060225 P030028 001
08717819060218 P030028 001
08717819060201 P030028 001
08717819060195 P030028 001
08717819060188 P030028 001
08717819060171 P030028 001
08717819060164 P030028 001
08717819060157 P030028 001
08717819060140 P030028 001
08717819060133 P030028 001
08717819060249 P030028 001
08717819060256 P030028 001
08717819060362 P030028 001
08717819060355 P030028 001
08717819060348 P030028 001
08717819060331 P030028 001
08717819060324 P030028 001
08717819060317 P030028 001
08717819060300 P030028 001
08717819060294 P030028 001
08717819060287 P030028 001
08717819060270 P030028 001
08717819060263 P030028 001
08717819060126 P030028 001

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.