SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P860040 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

DeviceSPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantWAVETOUCH TECHNOLOGIES, LLC
Date Received1990-09-17
Decision Date1990-11-19
PMAP860040
SupplementS009
Product CodeLPL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address WAVETOUCH TECHNOLOGIES, LLC 15970 Bernardo Center Dr. san Diego, CA 92127

Supplemental Filings

Supplement NumberDateSupplement Type
P860040Original Filing
S016 2004-05-05 Normal 180 Day Track No User Fee
S015 1998-05-19 Normal 180 Day Track
S014 1997-04-01 Normal 180 Day Track
S013 1995-02-28 Normal 180 Day Track
S012 1993-04-28 Normal 180 Day Track
S011 1992-01-23 Normal 180 Day Track
S010 1991-08-27 Normal 180 Day Track
S009 1990-09-17 Normal 180 Day Track
S008 1990-09-04 Normal 180 Day Track
S007 1989-08-28 Normal 180 Day Track
S006 1989-06-19 Normal 180 Day Track
S005
S004 1989-06-01 Normal 180 Day Track
S003 1989-03-14 Normal 180 Day Track
S002 1987-07-02 Normal 180 Day Track
S001 1987-02-10 Normal 180 Day Track

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