STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY
FDA premarket approval P080028 · decided 2016-01-08
Approval details
- PMA number
- P080028
- Trade name
- STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY
- Generic name
- Generator, shock-wave, for pain relief
- Applicant
- Storz Medical AG
- Date received
- 2008-11-26
- Decision date
- 2016-01-08
- Days to decision
- 2599 days
- Decision code
- APPR
- Product code
- NBN
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Tagerwilen
- Statement
- APPROVAL FOR THE STORZ MEDICAL DUOLITH SD1 SHOCK WAVE THERAPY. THIS DEVICE IS INDICATED FOR EXTRACORPOREAL SHOCK WAVE TREATMENT OF HEEL PAIN DUE TO CHRONIC PROXIMAL PLANTAR FASCIITIS FOR PATIENTS OF AGE GREATER THAN 18 YEARS WITH A HISTORY OF FAILED ALTERNATIVE CONSERVATIVE THERAPIES FOR AT LEAST SIX MONTHS. CHRONIC PROXIMAL PLANTAR FASCIITIS IS DEFINED AS TRACTION DEGENERATION OF THE PLANTAR FASCIAL BAND AT THE ORIGIN ON THE MEDIAL CALCANEAL TUBEROSITY THAT HAS PERSISTED FOR SIX MONTHS OR MORE.
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