SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P850077 S001

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 (METHAFILOCN A) HYDROPHILIC CONTACT LENS
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantCOOPER VISION, INC.
Date Received1985-10-02
Decision Date1986-06-25
Notice Date1986-08-07
PMAP850077
SupplementS001
Product CodeLPL
Docket Number86M-0310
Advisory CommitteeOphthalmic
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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