KONTUR SOFT (METHAFILCON A) LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P850078 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

DeviceKONTUR SOFT (METHAFILCON A) LENS
Classification NameLenses, Soft Contact, Daily Wear
Generic NameLenses, Soft Contact, Daily Wear
ApplicantKONTUR KONTACT LENS CO., INC.
Date Received1989-07-18
Decision Date1990-01-03
PMAP850078
SupplementS013
Product CodeLPL
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address KONTUR KONTACT LENS CO., INC. 642 Alfred Nobel Dr. hercules, CA 94547

Supplemental Filings

Supplement NumberDateSupplement Type
P850078Original Filing
S013 1989-07-18 Normal 180 Day Track
S012 1989-07-24 Normal 180 Day Track
S011
S010 1988-08-23 Normal 180 Day Track
S009
S008 1987-04-10 30-Day Supplement
S007 1987-04-15 Normal 180 Day Track
S006 1987-03-05 Normal 180 Day Track
S005
S004 1987-03-05 Normal 180 Day Track
S003 1987-03-05 Normal 180 Day Track
S002 1986-08-04 Normal 180 Day Track
S001 1985-10-02

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