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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.
 
DeviceEMS-SWISS DOLORCLAST
Generic NameGenerator, shock-wave, for pain relief
ApplicantElectro Medical Systems (Ems Sa)
Ch. De La Vuarpilliere 31
Nyon CH-1260
PMA NumberP050004
Supplement NumberS001
Date Received02/25/2009
Decision Date08/28/2009
Product Code NBN 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT E.M.S. ELECTRO MEDICAL SYSTEMS, SA, NYON, SWITZERLAND.
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