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: B&L STERILE SALINE SOLUTION UNIT DOSE
• Generic Name: Lenses, soft contact, extended wear
• Regulation Number: 886.5925
• Applicant: Bausch & Lomb, Inc.; 1400 N. Goodman St.; Rochester, NY 14609
• PMA Number: N16895
• Supplement Number: S012
• Date Received: 08/25/1980
• Decision Date: 12/04/1981
• Product Code: LPM
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No