BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P780007 S048

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 a new microbial air sampler and description for bioburden monitoring of the clean room.

DeviceBIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantCOOPERVISION, INC.
Date Received2012-01-12
Decision Date2012-02-09
PMAP780007
SupplementS048
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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