• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
Classification Namegenerator, shock-wave, for pain relief
Generic Namegenerator, shock-wave, for pain relief
Dornier MedTech America, Inc.
1155 roberts blvd.
kennesaw, GA 30144
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2