CONTACT LENSES

FDA Premarket Approval P820051 S012

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

DeviceCONTACT LENSES
Generic NameLenses, Soft Contact, Daily Wear
ApplicantOCU-EASE OPTICAL PRODUCTS, INC.
Date Received1989-12-15
Decision Date1991-02-15
PMAP820051
SupplementS012
Product CodeLPL 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address OCU-EASE OPTICAL PRODUCTS, INC. 629 Tennent Ave. pinole, CA 94564

Supplemental Filings

Supplement NumberDateSupplement Type
P820051Original Filing
S015 1992-02-18 Normal 180 Day Track
S014 1991-03-25 Normal 180 Day Track
S013
S012 1989-12-15 Normal 180 Day Track
S011
S010 1989-11-02 Normal 180 Day Track
S009 1989-09-22 Normal 180 Day Track
S008 1988-06-07 Normal 180 Day Track
S007
S006
S005
S004
S003 1986-06-03 Normal 180 Day Track
S002 1985-08-05
S001

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