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: CIBA VISION(R) STERILE BUFFERED AEROSOL SALINE
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Ciba Vision Corporation; 11460 Johns Creek Pkwy.; Duluth, GA 30097
• PMA Number: P880079
• Supplement Number: S010
• Date Received: 05/07/1991
• Decision Date: 07/15/1991
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No