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: SENSITIVE EYES(TM) SALINE & CLEANING SOLUTION
• Generic Name: Accessories, soft lens products
• Regulation Number: 886.5928
• Applicant: Bausch & Lomb, Inc.; 14853 Deveau Pl.; Minnetonka, MN 55345
• PMA Number: P820031
• Supplement Number: S005
• Date Received: 06/28/1984
• Decision Date: 09/09/1987
• Product Code: LPN
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No