TORAY SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P840044 S001

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

DeviceTORAY SOFT CONTACT LENSES
Classification NameLenses, Soft Contact, Extended Wear
Generic NameLenses, Soft Contact, Extended Wear
ApplicantToray Industries (America), Inc.
Date Received1989-07-19
Decision Date1989-12-19
PMAP840044
SupplementS001
Product CodeLPM
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Toray Industries (America), Inc. 1-1-1 Sonoyama otsu-shi, Shiga-ken 520 520

Supplemental Filings

Supplement NumberDateSupplement Type
P840044Original Filing
S002 1989-12-18 Normal 180 Day Track
S001 1989-07-19 Normal 180 Day Track

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