SOFTLENS(R) (POLYMACON) CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval N16895 S075

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

DeviceSOFTLENS(R) (POLYMACON) CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantBausch & Lomb, Inc.
Date Received1991-05-10
Decision Date1991-08-08
PMAN16895
SupplementS075
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Bausch & Lomb, Inc. 1400 North Goodman St. rochester, NY 14609-3547

Supplemental Filings

Supplement NumberDateSupplement Type
N16895Original Filing
S105 2022-02-18 30-day Notice
S104
S103 2020-03-20 30-day Notice
S102 2018-07-05 30-day Notice
S101 2018-05-15 30-day Notice
S100 2017-07-14 30-day Notice
S099 2016-07-21 Real-time Process
S098 2016-07-15 30-day Notice
S097 2015-08-03 30-day Notice
S096 2014-09-02 30-day Notice
S095 2014-01-03 135 Review Track For 30-day Notice
S094 2011-10-19 135 Review Track For 30-day Notice
S093 2011-02-08 30-day Notice
S092 2011-01-10 30-day Notice
S091 2008-11-12 Real-time Process
S090 2008-09-24 Real-time Process
S089 2005-10-18 Normal 180 Day Track No User Fee
S088 2001-01-09 Normal 180 Day Track
S087 1999-11-16 Normal 180 Day Track
S086 1999-10-26 30-day Notice
S085 1997-08-07 Normal 180 Day Track
S084 1996-10-01 Normal 180 Day Track
S083 1994-11-18 Normal 180 Day Track
S082 1993-08-12 Normal 180 Day Track
S081 1992-12-01 Normal 180 Day Track
S080 1991-11-18 Normal 180 Day Track
S079 1991-08-27 Normal 180 Day Track
S078
S077 1991-06-18 Normal 180 Day Track
S076 1991-06-05 Normal 180 Day Track
S075 1991-05-10 Normal 180 Day Track
S074 1991-05-02 Normal 180 Day Track
S073
S072
S071 1990-11-05 Normal 180 Day Track
S070 1990-11-05 Normal 180 Day Track
S069 1990-08-23 Normal 180 Day Track
S068 1990-07-03 Normal 180 Day Track
S067 1990-03-08 Normal 180 Day Track
S066 1989-08-29 Normal 180 Day Track
S065
S064 1989-08-28 Normal 180 Day Track
S063 1989-07-24 Normal 180 Day Track
S062 1989-07-24 Normal 180 Day Track
S061 1989-07-21 Normal 180 Day Track
S060 1989-05-25 Normal 180 Day Track
S059 1989-01-03 Normal 180 Day Track
S058 1988-12-09 Normal 180 Day Track
S057 1988-12-09 Normal 180 Day Track
S056 1988-12-08 Normal 180 Day Track
S055 1988-12-06 Normal 180 Day Track
S054 1988-09-20 Normal 180 Day Track
S053 1988-08-05 Special (immediate Track)
S052 1988-07-29 Normal 180 Day Track
S051 1987-10-15 Normal 180 Day Track
S050 1987-09-02 Normal 180 Day Track
S049 1987-08-06 30-Day Supplement
S048 1987-05-15 Normal 180 Day Track
S047 1987-02-02 30-Day Supplement
S046 1987-01-21 Normal 180 Day Track
S045 1987-01-05 Normal 180 Day Track
S044 1986-08-20 Normal 180 Day Track
S043 1986-04-22
S042 1986-03-18 Normal 180 Day Track
S041 1986-03-18
S040 1985-08-30
S039
S038 1985-03-20
S037 1985-02-07
S036 1984-07-23
S035
S034
S033 1984-06-22
S032
S031 1984-05-08
S030
S029 1983-11-14
S028 1983-04-13
S027 1982-12-27
S026 1982-12-16
S025 1982-08-25
S024 1982-07-20
S023 1982-05-20
S022
S021 1982-02-19
S020 1981-12-17
S019 1981-10-19
S018 1981-07-29
S017 1981-05-05
S016
S015 1980-12-30
S014 1980-09-26
S013 1980-08-25
S012 1980-08-25
S011 1980-08-15
S010 1980-08-01
S009 1980-05-05
S008 1980-04-21
S007 1980-02-05
S006 1979-08-02
S005 1979-07-13
S004 1979-06-06
S003 1979-02-15
S002 1978-12-11
S001 1979-03-02 Normal 180 Day Track

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