|
Device | DORNIER EPOS ULTRA |
Generic Name | Generator, shock-wave, for pain relief |
Applicant | Dornier MedTech America, Inc. 1155 ROBERTS BLVD. KENNESAW, GA 30144 |
PMA Number | P000048 |
Date Received | 11/21/2000 |
Decision Date | 01/15/2002 |
Withdrawal Date
|
08/15/2018 |
Product Code |
NBN |
Docket Number | 02M-0034 |
Notice Date | 01/25/2002 |
Advisory Committee |
Orthopedic |
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 |
Supplements: |
|
|
|