POLYCON CONTACT LENS

FDA Premarket Approval N18120 S017

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 Received1987-05-18
Decision Date1988-04-28
PMAN18120
SupplementS017
Product CodeHPX 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
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

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