CUSTOMEYES(TM) 45L&55L (BUFILCON A)

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P850057 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: CUSTOMEYES(TM) 45L&55L (BUFILCON A)
• Classification Name: Lenses, Soft Contact, Extended Wear
• Generic Name: Lenses, Soft Contact, Extended Wear
• Applicant: CIBA VISION CORPORATION
• Date Received: 1986-07-28
• Decision Date: 1987-05-08
• Notice Date: 1987-06-29
• PMA: P850057
• Supplement: S001
• Product Code: LPM
• Docket Number: 87M-0191
• 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: CIBA VISION CORPORATION 11460 Johns Creek Parkway duluth, GA 30097

Supplemental Filings

Supplement Number	Date	Supplement Type
P850057		Original Filing
S006	1999-12-23	Normal 180 Day Track
S005	1995-05-15	Normal 180 Day Track
S004	1989-07-24	Normal 180 Day Track
S003	1986-12-23	Normal 180 Day Track
S002	1986-12-04	Normal 180 Day Track
S001	1986-07-28	Normal 180 Day Track