DURASOFT CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval N17852 S028

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

DeviceDURASOFT CONTACT LENS
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantWESLEY JESSEN CORP.
Date Received1989-02-09
Decision Date1989-08-28
PMAN17852
SupplementS028
Product CodeLPL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 400 West Superior St. chicago, IL 60610

Supplemental Filings

Supplement NumberDateSupplement Type
N17852Original Filing
S033 1991-04-10 Normal 180 Day Track
S032 1989-09-18 Normal 180 Day Track
S031 1989-09-11 Normal 180 Day Track
S030 1989-08-07 Normal 180 Day Track
S029 1989-03-17 Normal 180 Day Track
S028 1989-02-09 Normal 180 Day Track
S027 1988-12-16 Normal 180 Day Track
S026 1988-03-08 Normal 180 Day Track
S025 1987-07-29 Normal 180 Day Track
S024 1987-07-28 Normal 180 Day Track
S023 1987-07-24 Normal 180 Day Track
S022 1987-07-27 Normal 180 Day Track
S021 1987-07-08 30-Day Supplement
S020 1987-06-08 30-Day Supplement
S019 1987-06-08 30-Day Supplement
S018 1987-05-22 Normal 180 Day Track
S017 1987-05-22 Normal 180 Day Track
S016 1986-10-08 Special (immediate Track)
S015 1986-03-10 Normal 180 Day Track
S014 1985-11-04
S013 1985-01-04
S012 1984-11-21
S011 1983-09-12
S010 1983-03-01
S009 1982-12-30
S008 1982-07-22
S007 1981-11-12
S006 1981-05-27
S005 1981-02-02
S004 1980-09-02
S003 1980-07-08
S002 1979-10-12
S001 1978-12-11

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