SUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P850077 S020

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

DeviceSUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)CONTACT LEN
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCOOPER VISION, INC.
Date Received1994-09-27
Decision Date1995-05-05
PMAP850077
SupplementS020
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address COOPER VISION, INC. 6150 Stoneridge Mall Road suite 370 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P850077Original Filing
S024 1997-05-07 Normal 180 Day Track
S023 1997-04-16 Normal 180 Day Track
S022 1996-11-22 Normal 180 Day Track
S021 1994-12-19 Normal 180 Day Track
S020 1994-09-27 Normal 180 Day Track
S019 1994-01-26 Normal 180 Day Track
S018 1992-03-06 Normal 180 Day Track
S017 1992-02-26 Normal 180 Day Track
S016
S015 1991-02-21 Normal 180 Day Track
S014 1991-01-18 Normal 180 Day Track
S013 1990-01-05 Normal 180 Day Track
S012 1989-11-09 Normal 180 Day Track
S011 1989-07-20 Normal 180 Day Track
S010 1988-11-14 Normal 180 Day Track
S009
S008 1988-04-07 Normal 180 Day Track
S007
S006 1988-01-19 Normal 180 Day Track
S005 1987-11-02 Normal 180 Day Track
S004 1986-12-11 30-Day Supplement
S003
S002 1986-07-28 Normal 180 Day Track
S001 1985-10-02

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