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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameEMS SWISS DOLORCLAST
Classification Namegenerator, shock-wave, for pain relief
Generic Nameorthopedic lithotripter
ApplicantELECTRO MEDICAL SYSTEMS (EMS SA)
PMA NumberP050004
Date Received02/02/2005
Decision Date05/08/2007
Product Code
NBN[ Registered Establishments with NBN ]
Docket Number 07M-0253
Notice Date 06/28/2007
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approal for the ems swiss dolorclast. The ems swiss dolorclast is a non-surgical alternative indicated for the treatment of chronic proximal plantar fasciitis for patients 18 years of age or older with symptoms for 6 months or more and a history of unsuccessful conservative therapy. Chronic proximal plantar fasciitis is defined as heel pain in the area of the insertion of the plantar fascia on the medical calcaneal tuberosity.
Approval Order Approval Order
Supplements: S001 
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