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: CRYSTALENS SALINE SPRAY
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Stericon, Inc.; 19742 Macarthur Blvd.; Suite 235; Irvine, CA 92715
• PMA Number: P850065
• Supplement Number: S001
• Date Received: 02/25/1986
• Decision Date: 06/27/1986
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No