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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Classification Namegenerator, shock-wave, for pain relief
Generic Nameextracorporeal shockwave therapy
PMA NumberP000048
Date Received11/21/2000
Decision Date01/15/2002
Product Code
NBN[ Registered Establishments with NBN ]
Docket Number 02M-0034
Notice Date 01/25/2002
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 
Approval for the dornier epos ultra. The dornier epos ultra is a non-surgical alternative for the treatment of chronic plantar fasciitis for patients with symptoms of plantar fasciitis for 6 months or more and a history of unsuccessful conservative therapy. Plantar fasciitis is defined as the traction degeneration of the plantar fascial band at its origin on the medical tubercle of the calcaneus.
Approval Order Approval Order