CIBA 2000(TM) (ATLAFILCON A) SOFT CONTACT LENS

Lenses, Soft Contact, Daily Wear

FDA Premarket Approval P890029 S003

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: CIBA 2000(TM) (ATLAFILCON A) SOFT CONTACT LENS
• Classification Name: Lenses, Soft Contact, Daily Wear
• Generic Name: Lenses, Soft Contact, Daily Wear
• Applicant: CIBA VISION CORPORATION
• Date Received: 1990-12-31
• Decision Date: 1992-09-11
• Notice Date: 1993-05-03
• PMA: P890029
• Supplement: S003
• Product Code: LPL
• Docket Number: 92M-0390
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/components/specifications/material
• 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
P890029		Original Filing
S003	1990-12-31	Normal 180 Day Track
S002	1990-01-29	Normal 180 Day Track
S001	1989-12-05	Normal 180 Day Track