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. |
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Device | EMS-SWISS DOLORCLAST |
Generic Name | Generator, shock-wave, for pain relief |
Applicant | ELECTRO MEDICAL SYSTEMS (EMS SA) CH. DE LA VUARPILLIERE 31 NYON, VAUD CH-12-1260 |
PMA Number | P050004 |
Supplement Number | S001 |
Date Received | 02/25/2009 |
Decision Date | 08/28/2009 |
Product Code |
NBN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT E.M.S. ELECTRO MEDICAL SYSTEMS, SA, NYON, SWITZERLAND. |
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