POLYCON CONTACT LENS

FDA Premarket Approval N18120 S014

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

DevicePOLYCON CONTACT LENS
Generic NameLens, Contact (polymethylmethacrylate)
ApplicantWESLEY JESSEN CORP.
Date Received1984-05-01
Decision Date1985-04-30
PMAN18120
SupplementS014
Product CodeHPX 
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 333 E. Howard Ave. des Plaines, IL 60018-5903

Supplemental Filings

Supplement NumberDateSupplement Type
N18120Original Filing
S027 1990-12-28 Normal 180 Day Track
S026 1990-07-02 Normal 180 Day Track
S025 1990-06-21 30-Day Supplement
S024 1989-09-19 Normal 180 Day Track
S023 1989-07-24 Normal 180 Day Track
S022 1988-05-27 Panel Track
S021 1988-05-17 Normal 180 Day Track
S020
S019 1987-12-15 Normal 180 Day Track
S018 1987-05-26 30-Day Supplement
S017 1987-05-18 Normal 180 Day Track
S016 1985-02-15
S015 1984-11-13
S014 1984-05-01
S013 1984-04-27
S012 1983-03-30
S011 1982-11-26
S010 1982-07-06
S009 1982-02-23
S008 1981-05-28
S007 1980-08-01
S006 1980-07-28
S005 1980-06-26
S004
S003 1979-05-14
S002 1981-03-08
S001

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