PHYSIO-STIM BONE GROWTH STIMULATOR
FDA premarket approval P850007/S025 · decided 2000-05-31
Approval details
- PMA number
- P850007
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHYSIO-STIM BONE GROWTH STIMULATOR
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix, Inc.
- Date received
- 2000-03-13
- Decision date
- 2000-05-31
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- APPROVAL TO MODIFY THE PHYSIO-STIM, MODEL 7215 AS FOLLOWS: 1. COMBINE THE TRANSDUCER AND CONTROL UNITS INTO A SINGLE UNIT; 2. POWER THE DEVICE WITH ONE 9-VOLT DISPOSABLE BATTERY RATHER THAN A MULTIPLE CELL NI-CAD BATTERY PACK WITH CHARGER UNIT; 3. BASED ON THE ABOVE CHANGES, REDUCE THE WEIGHT AND OVERALL DIMENSIONS OF THE DEVICE; 4. INDICATE THE OPERATING STATUS OF THE DEVICE WITH THREE LED SIGNAL LIGHTS RATHER THAN AN LCD READOUT; AND 5. CONTROL POWER TO THE DEVICE WITH AN ON/OFF BUTTON RATHER
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