X-70 SOFT CONTACT LENS

Lenses, Soft Contact, Extended Wear

FDA Premarket Approval P830047 S004

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: X-70 SOFT CONTACT LENS
• Classification Name: Lenses, Soft Contact, Extended Wear
• Generic Name: Lenses, Soft Contact, Extended Wear
• Applicant: ADVANCED MEDICAL OPTICS, INC.
• Date Received: 1989-07-20
• Decision Date: 1989-12-28
• PMA: P830047
• Supplement: S004
• Product Code: LPM
• 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: ADVANCED MEDICAL OPTICS, INC. 1700 E. St. Andrew Place p.o. Box 25162 santa Ana, CA 92705-4933

Supplemental Filings

Supplement Number	Date	Supplement Type
P830047		Original Filing
S006	1991-04-18	Normal 180 Day Track
S005
S004	1989-07-20	Normal 180 Day Track
S003	1987-08-04	Normal 180 Day Track
S002	1987-07-21	Normal 180 Day Track
S001	1986-09-12	Normal 180 Day Track