TETRAFILCON A

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval N17679 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

Approval for an alternate tinting process, in-monomer-tinting process.

DeviceTETRAFILCON A
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCOOPERVISION, INC.
Date Received1999-02-23
Decision Date1999-03-17
PMAN17679
SupplementS034
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address COOPERVISION, INC. 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
N17679Original Filing
S040 2018-06-07 30-day Notice
S039 2018-01-16 135 Review Track For 30-day Notice
S038 2017-10-23 30-day Notice
S037 2017-09-20 30-day Notice
S036 2013-08-19 30-day Notice
S035
S034 1999-02-23 Normal 180 Day Track
S033
S032 1998-02-17 Normal 180 Day Track
S031
S030 1995-03-29 30-Day Supplement
S029 1995-03-01 Normal 180 Day Track
S028 1993-08-20 Normal 180 Day Track
S027 1993-07-20 Normal 180 Day Track
S026
S025 1991-03-21 Normal 180 Day Track
S024 1990-12-07 Normal 180 Day Track
S023 1990-09-13 Normal 180 Day Track
S022 1990-05-03 Normal 180 Day Track
S021 1989-07-24 Normal 180 Day Track
S020 1989-04-12 Normal 180 Day Track
S019 1989-02-22 Normal 180 Day Track
S018 1988-05-12 Special (immediate Track)
S017 1988-03-24 Special (immediate Track)
S016 1987-11-09 Special (immediate Track)
S015 1987-10-26 Normal 180 Day Track
S014 1987-10-01 Special (immediate Track)
S013 1987-09-10 Normal 180 Day Track
S012 1986-03-03
S011 1986-01-08
S010 1986-01-06
S009 1985-05-30
S008 1984-12-21
S007 1984-08-07
S006 1984-07-02
S005
S004
S003 1980-01-08
S002
S001 1979-05-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.