UNISOL

Accessories, Soft Lens Products

FDA Premarket Approval P790011 S007

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

DeviceUNISOL
Classification NameAccessories, Soft Lens Products
Generic NameAccessories, Soft Lens Products
ApplicantWESLEY JESSEN CORP.
Date Received1983-04-18
Decision Date1983-06-07
PMAP790011
SupplementS007
Product CodeLPN
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address WESLEY JESSEN CORP. 400 West Superior St. chicago, IL 60610

Supplemental Filings

Supplement NumberDateSupplement Type
P790011Original Filing
S020 1994-08-26 Special (immediate Track)
S019
S018 1989-05-12 Normal 180 Day Track
S017 1989-04-25 Normal 180 Day Track
S016 1989-02-13 Normal 180 Day Track
S015 1987-11-05 Normal 180 Day Track
S014 1987-10-26 Normal 180 Day Track
S013 1987-06-11 30-Day Supplement
S012 1987-04-13 Normal 180 Day Track
S011 1986-11-18 Normal 180 Day Track
S010 1985-04-23
S009 1983-09-13
S008 1983-07-13
S007 1983-04-18
S006 1982-06-25
S005 1982-06-08
S004
S003 1981-04-28
S002 1981-04-02
S001 1980-06-24

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