TORAY SOFT CONTACT LENSES

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P840044 S002

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

• Device: TORAY SOFT CONTACT LENSES
• Classification Name: Lenses, Soft Contact, Extended Wear
• Generic Name: Lenses, Soft Contact, Extended Wear
• Applicant: Toray Industries (America), Inc.
• Date Received: 1989-12-18
• Decision Date: 1990-02-01
• PMA: P840044
• Supplement: S002
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: Toray Industries (America), Inc. 1-1-1 Sonoyama otsu-shi, Shiga-ken 520 520

Supplemental Filings

Supplement Number	Date	Supplement Type
P840044		Original Filing
S002	1989-12-18	Normal 180 Day Track
S001	1989-07-19	Normal 180 Day Track