Premarket Approval (PMA)

• Device: HMT SHOCK PLUG/LITHOTRIPTER ELECTRODE
• Generic Name: Lithotriptor, extracorporeal shock-wave, urological
• Regulation Number: 876.5990
• Applicant: Towers Perrin; 335 Madison Ave.; New York, NY 10017-4605
• PMA Number: P870011
• Date Received: 02/27/1987
• Decision Date: 09/06/1990
• Reclassified Date: 09/08/2000
• Product Code: LNS
• Docket Number: 90m-0303
• Notice Date: 10/19/1990
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No