PERMATINT(R)

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P820059 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

DevicePERMATINT(R)
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantWESLEY JESSEN CORP.
Date Received1984-09-04
Decision Date1984-11-30
PMAP820059
SupplementS006
Product CodeLPL
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
P820059Original Filing
S020 1992-10-01 Normal 180 Day Track
S019 1992-09-23 Normal 180 Day Track
S018 1991-05-01 Normal 180 Day Track
S017
S016 1989-08-23 Normal 180 Day Track
S015 1989-07-24 Normal 180 Day Track
S014
S013 1987-02-09 Normal 180 Day Track
S012 1986-12-04 Normal 180 Day Track
S011 1986-08-05 Normal 180 Day Track
S010 1986-06-24 Normal 180 Day Track
S009 1985-08-12
S008 1984-06-07
S007 1985-06-19
S006 1984-09-04
S005 1984-09-04
S004 1984-06-07
S003 1984-04-26
S002 1984-03-15
S001 1983-10-21

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