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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceSONOCUR BASIC EXTRACORPOREAL SHOCK WAVE THERAPY (ESWT)
Classification Namegenerator, shock-wave, for pain relief
Generic Namegenerator, shock-wave, for pain relief
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern, PA 19355-1406
PMA NumberP010039
Supplement NumberS003
Date Received10/28/2004
Decision Date09/27/2005
Product Code
NBN[ Registered Establishments with NBN ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATIONS TO THE POST-APPROVAL PROTOCOL.
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