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: TENNANT(TM) & KELMAN(TM) TYPE II
• Generic Name: Transducer, ultrasonic, obstetric
• Regulation Number: 884.2960
• Applicant: Bausch & Lomb, Inc.; 1400 N. Goodman St.; Rochester, NY 14609
• PMA Number: P800016
• Supplement Number: S006
• Date Received: 12/10/1985
• Decision Date: 01/08/1986
• Withdrawal Date: 11/26/2008
• Product Code: HGL
• Advisory Committee: Ophthalmic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No