Menicon Z Night (tisilfocon A) COntact Lenses for Overnight Wear

Lens, Contact (rigid Gas Permeable), Extended Wear

FDA Premarket Approval P990018 S005

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 manufacture, market and distribute overnight orthokeratology contact lenses from the menicon z™ (tisilfocon a) rigid gas permeable contact lens material, which is fda approved for extended wear under p990018

DeviceMenicon Z Night (tisilfocon A) COntact Lenses for Overnight Wear
Classification NameLens, Contact (rigid Gas Permeable), Extended Wear
Generic NameLens, Contact (rigid Gas Permeable), Extended Wear
ApplicantMENICON CO. LTD.
Date Received2018-11-28
Decision Date2019-11-06
PMAP990018
SupplementS005
Product CodeMWL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address MENICON CO. LTD. 269 A Ballardvale Street wilmington, MA 01887

Supplemental Filings

Supplement NumberDateSupplement Type
P990018Original Filing
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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