ORBASONE PAIN RELIEF SYSTEM
FDA premarket approval P040039 · decided 2005-08-10
Approval details
- PMA number
- P040039
- Trade name
- ORBASONE PAIN RELIEF SYSTEM
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Orthometrix, Inc.
- Date received
- 2004-09-14
- Decision date
- 2005-08-10
- Days to decision
- 330 days
- Decision code
- APWD
- Product code
- NBN
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Naples, FL
- Statement
- APPROVAL FOR THE ORBASONE PAIN RELIEF SYSTEM. THE DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE THERAPY FOR THE TREATMENT OF CHRONIC PROXIMAL PLANTAR FASCIITIS IN PATIENTS 18 YEARS OF AGE OR OLDER THAT HAVE FAILED TO RESPOND TO CONSERVATIVE THERAPY. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS HEEL PAIN IN THE AREA OF THE INSERTION OF THE PLANTAR FASCIA ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
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