DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P850072 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: DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
• Classification Name: Lenses, Soft Contact, Extended Wear
• Generic Name: Lenses, Soft Contact, Extended Wear
• Applicant: CIBA VISION CORPORATION
• Date Received: 1987-11-12
• Decision Date: 1988-02-24
• Notice Date: 1988-03-30
• PMA: P850072
• Supplement: S002
• Product Code: LPM
• Docket Number: 88M-0082
• Advisory Committee: Ophthalmic
• Supplement Type: Panel 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
P850072		Original Filing
S007	1989-09-25	Normal 180 Day Track
S006	1989-09-18	Normal 180 Day Track
S005	1989-09-11	Normal 180 Day Track
S004	1989-07-20	Normal 180 Day Track
S003	1989-02-09	Normal 180 Day Track
S002	1987-11-12	Panel Track
S001	1986-08-05	Normal 180 Day Track