WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P800011 S010

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: WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES
• Classification Name: Lenses, Soft Contact, Daily Wear
• Generic Name: Lenses, Soft Contact, Daily Wear
• Applicant: CIBA VISION CORPORATION
• Date Received: 1989-10-24
• Decision Date: 1989-12-19
• PMA: P800011
• Supplement: S010
• Product Code: LPL
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: CIBA VISION CORPORATION 11460 Johns Creek Pkwy. duluth, GA 30097

Supplemental Filings

Supplement Number	Date	Supplement Type
P800011		Original Filing
S010	1989-10-24	Normal 180 Day Track
S009	1988-04-14	Normal 180 Day Track
S008	1987-12-30	Normal 180 Day Track
S007	1985-10-30
S006	1984-01-30
S005	1982-05-27
S004	1981-09-14
S003
S002	1980-10-27
S001