UNISOL

Accessories, Soft Lens Products

FDA Premarket Approval P790011 S013

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 Received1987-06-11
Decision Date1987-07-02
PMAP790011
SupplementS013
Product CodeLPN
Advisory CommitteeOphthalmic
Supplement Type30-Day Supplement
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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