TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P870079 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

• Device: TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS
• Classification Name: Lenses, Soft Contact, Daily Wear
• Generic Name: Lenses, Soft Contact, Daily Wear
• Applicant: UNITED CONTACT LENS, INC.
• Date Received: 1988-11-04
• Decision Date: 1989-05-26
• PMA: P870079
• Supplement: S001
• Product Code: LPL
• 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: UNITED CONTACT LENS, INC. 917-134th St. S.w., #a-4 everett, WA 98204

Supplemental Filings

Supplement Number	Date	Supplement Type
P870079		Original Filing
S005	1989-08-25	Normal 180 Day Track
S004
S003	1989-08-03	Normal 180 Day Track
S002	1988-11-07	Normal 180 Day Track
S001	1988-11-04	Normal 180 Day Track