NEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES

FDA Premarket Approval P820021 S021

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

DeviceNEW VUES (TM)(VIFILCON A)(HYDROPHILIC)SOFT LENSES
Generic NameLenses, Soft Contact, Extended Wear
ApplicantAlcon Laboratories, Inc.
Date Received1990-03-28
Decision Date1990-08-17
PMAP820021
SupplementS021
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address Alcon Laboratories, Inc. 6201 South Freeway fort Worth, TX 76134-2099

Supplemental Filings

Supplement NumberDateSupplement Type
P820021Original Filing
S036 2013-04-10 30-day Notice
S035 2012-11-19 30-day Notice
S034 2012-07-05 30-day Notice
S033 2011-05-09 30-day Notice
S032
S031 2006-08-22 Real-time Process
S030 2001-10-16 Normal 180 Day Track
S029 1996-05-10 Normal 180 Day Track
S028 1995-06-27 Normal 180 Day Track
S027 1995-05-15 30-Day Supplement
S026 1995-02-17 Special (immediate Track)
S025 1995-01-17 Normal 180 Day Track
S024 1994-02-02 Normal 180 Day Track
S023 1991-04-03 Normal 180 Day Track
S022 1990-10-31 Normal 180 Day Track
S021 1990-03-28 Normal 180 Day Track
S020
S019 1989-11-22 Normal 180 Day Track
S018 1989-10-10 Normal 180 Day Track
S017 1989-07-24 Normal 180 Day Track
S016 1989-03-01 Normal 180 Day Track
S015 1988-12-21 Normal 180 Day Track
S014 1988-05-23 Normal 180 Day Track
S013 1988-04-04 Normal 180 Day Track
S012 1988-01-12 Normal 180 Day Track
S011
S010 1987-07-01 Normal 180 Day Track
S009 1987-02-02 Normal 180 Day Track
S008 1986-03-18
S007 1986-03-04
S006 1986-03-07
S005 1986-02-05
S004
S003 1985-01-10
S002 1983-05-17
S001 1983-06-07

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