SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P860040

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceSPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantWAVETOUCH TECHNOLOGIES, LLC
Date Received1986-08-28
Decision Date1987-02-19
Notice Date1987-04-07
PMAP860040
SupplementS
Product CodeLPM
Docket Number87M-0073
Advisory CommitteeOphthalmic
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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