DURASOFT CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval N17852 S006

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 Received1981-05-27
Decision Date1982-08-27
PMAN17852
SupplementS006
Product CodeLPL
Advisory CommitteeOphthalmic
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.