VIFILCON A SOFT CONTACT LENSES

FDA Premarket Approval P820021 S034

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

Change in raw material test method.

DeviceVIFILCON A SOFT CONTACT LENSES
Generic NameLenses, Soft Contact, Extended Wear
ApplicantAlcon Laboratories, Inc.
Date Received2012-07-05
Decision Date2012-07-30
PMAP820021
SupplementS034
Product CodeLPM 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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