STAY WET 3 & STAY WET 3 (SA)

Accessories, Soft Lens Products

FDA Premarket Approval P870029 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: STAY WET 3 & STAY WET 3 (SA)
• Classification Name: Accessories, Soft Lens Products
• Generic Name: Accessories, Soft Lens Products
• Applicant: ADVANCED MEDICAL OPTICS, INC.
• Date Received: 1989-08-21
• Decision Date: 1989-12-28
• PMA: P870029
• Supplement: S003
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: ADVANCED MEDICAL OPTICS, INC. 2525 Dupont Dr. irvine, CA 92612

Supplemental Filings

Supplement Number	Date	Supplement Type
P870029		Original Filing
S009	1993-03-19	Normal 180 Day Track
S008
S007	1992-05-27	Normal 180 Day Track
S006
S005
S004	1990-07-09	Normal 180 Day Track
S003	1989-08-21	Normal 180 Day Track
S002
S001