MENICON Z

Lens, Contact (rigid Gas Permeable), Extended Wear

FDA Premarket Approval P990018 S003

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

Approval for alcon unique-ph multi-purpose solution as an alternate wet shipping solution for the menicon z rigid gas permeable contact lens.

DeviceMENICON Z
Classification NameLens, Contact (rigid Gas Permeable), Extended Wear
Generic NameLens, Contact (rigid Gas Permeable), Extended Wear
ApplicantMENICON CO. LTD.
Date Received2002-10-21
Decision Date2002-11-06
PMAP990018
SupplementS003
Product CodeMWL
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address MENICON CO. LTD. 21-19, Aoi 3-chome, Naka-ku nagoya Aichi 460-0-0006

Supplemental Filings

Supplement NumberDateSupplement Type
P990018Original Filing
S008 2022-02-07 Normal 180 Day Track
S007
S006 2021-01-21 Normal 180 Day Track No User Fee
S005 2018-11-28 Normal 180 Day Track
S004 2009-04-01 Normal 180 Day Track No User Fee
S003 2002-10-21 Real-time Process
S002 2001-11-28 Panel Track
S001 2000-07-28 Normal 180 Day Track

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