POLYMACON SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P780007 S051

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

Addition of new equipment to measure airborne particles at the juana diaz, puerto rico facility.

DevicePOLYMACON SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCOOPERVISION, INC.
Date Received2013-07-22
Decision Date2013-08-20
PMAP780007
SupplementS051
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address COOPERVISION, INC. 370 Woodcliff Drive suite 200 fairport, NY 14450-0000

Supplemental Filings

Supplement NumberDateSupplement Type
P780007Original Filing
S062 2019-08-13 30-day Notice
S061 2018-03-16 135 Review Track For 30-day Notice
S060 2018-03-05 Real-time Process
S059 2018-01-16 135 Review Track For 30-day Notice
S058 2017-10-24 30-day Notice
S057
S056 2017-01-30 30-day Notice
S055 2017-01-08 30-day Notice
S054 2015-07-02 30-day Notice
S053 2013-11-13 135 Review Track For 30-day Notice
S052 2013-11-12 30-day Notice
S051 2013-07-22 30-day Notice
S050
S049 2012-01-12 30-day Notice
S048 2012-01-12 30-day Notice
S047 2012-01-12 30-day Notice
S046 2011-09-22 30-day Notice
S045 2011-02-24 30-day Notice
S044 2008-10-23 30-day Notice
S043 2003-01-10 Normal 180 Day Track No User Fee
S042 1999-09-17 Normal 180 Day Track
S041 1996-02-06 Normal 180 Day Track
S040
S039 1993-04-15 Normal 180 Day Track
S038 1992-05-11 Normal 180 Day Track
S037 1991-04-17 Normal 180 Day Track
S036 1990-10-31 Normal 180 Day Track
S035 1990-08-01 Normal 180 Day Track
S034 1989-07-20 Normal 180 Day Track
S033 1989-05-09 Normal 180 Day Track
S032 1988-10-31 Normal 180 Day Track
S031 1988-07-08 Normal 180 Day Track
S030
S029 1988-02-12 Normal 180 Day Track
S028 1988-01-21 Panel Track
S027 1987-04-28 30-Day Supplement
S026 1986-12-29 Normal 180 Day Track
S025 1986-10-30 Normal 180 Day Track
S024 1986-09-22 Normal 180 Day Track
S023 1985-02-25
S022
S021
S020 1984-11-07
S019 1984-10-11
S018 1984-10-09
S017 1984-09-10
S016 1984-07-27
S015 1984-01-26
S014 1983-09-02
S013
S012 1982-04-29
S011
S010 1982-04-29
S009 1982-03-09
S008 1981-07-31
S007 1980-11-07 Normal 180 Day Track
S006 1980-04-15
S005 1980-02-01
S004 1979-11-19
S003 1979-10-31
S002 1979-10-31
S001 1979-09-27 Normal 180 Day Track

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