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: SONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)
• Generic Name: Generator, shock-wave, for pain relief
• Applicant: SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 VALLEY STREAM PKWY.; MALVERN, PA 19355-1406
• PMA Number: P010039
• Supplement Number: S003
• Date Received: 10/28/2004
• Decision Date: 09/27/2005
• Withdrawal Date: 08/05/2016
• Product Code: NBN
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL PROTOCOL.