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: MODEL MFL5000 EXPANSION OF INDICATION RANGE
• Generic Name: Lithotriptor, extracorporeal shock-wave, urological
• Regulation Number: 876.5990
• Applicant: Dornier Medtech America, Inc.; 1155 Roberts Blvd.; Kennesaw, GA 30144
• PMA Number: P840008
• Supplement Number: S040
• Date Received: 05/11/1992
• Decision Date: 03/08/1993
• Reclassified Date: 09/08/2000
• Product Code: LNS
• Docket Number: 93M-0124
• Advisory Committee: Gastroenterology/Urology
• Supplement Type: Panel Track
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No