VIS-SOL STERILE PRESERVED SALINE SOLUTION

FDA Premarket Approval P870017 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: VIS-SOL STERILE PRESERVED SALINE SOLUTION
• Generic Name: Accessories, Soft Lens Products
• Applicant: VISIONCARE ASSOC.480 Southsan Vicente Boulevardlos Angeles, CA 90048 PMA NumberP870017 Supplement NumberS001 Date Received07/21/1987 Decision Date10/19/1987 Product Code LPN Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Date Received: 1987-07-21
• Decision Date: 1987-10-19
• PMA: P870017
• Supplement: S001
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: VISIONCARE ASSOC.; 480 South; san Vicente Boulevard; los Angeles, CA 90048 PMA NumberP870017 Supplement NumberS001 Date Received07/21/1987 Decision Date10/19/1987 Product Code LPN Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo

Supplemental Filings

Supplement Number	Date	Supplement Type
P870017		Original Filing
S002	1990-01-10	Normal 180 Day Track
S001	1987-07-21	Normal 180 Day Track