PMA P000048
- Device
- DORNIER EPOS ULTRA
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P000048
- Product code
- NBN
- Decision date
- 2002-01-15
- Classification
- Orthopedic
- Generic name
- Generator, shock-wave, for pain relief
- 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.
Current openFDA PMA Record#
- Device
- DORNIER EPOS ULTRA
- Applicant
- Dornier Medtech America, Inc.
- PMA number
- P000048
- Product code
- NBN
- Generic name
- Generator, shock-wave, for pain relief
- Decision date
- 2002-01-15
- Decision code
- APWD
- Date received
- 2000-11-21
- 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.