Premarket Approval (PMA)

Note: 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.

• Device: APPLIED LABORATORIES STERILE SALINE SOLUTION
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Applied Laboratories, Inc.; 3240 N. Indianapolis Rd.; P.O. Box 448; Columbus, IN 47201
• PMA Number: P870002
• Supplement Number: S006
• Date Received: 08/24/1989
• Decision Date: 02/16/1990
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No