EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))
FDA premarket approval P900009/S013 · decided 2001-09-04
Approval details
- PMA number
- P900009
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R))
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2001-04-30
- Decision date
- 2001-09-04
- Days to decision
- 127 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR THE LOW INTENSITY ULTRASOUND FRACTURE TREATMENT SYSTEM-SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EXOGEN 2000+(TM) SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) AND IS INDICATED FOR THE NON-INVASIVE TREATMENT OF ESTBLISHED NONUNIONS* EXLUDING SKULL AND VERTEBRA. IN ADDITION, THE EXOGEN 2000+(TM) OR SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS(R)) IS INDICATED FOR ACCELERATING THE TIME TO A HEALED FR
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