EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
FDA premarket approval P900009/S025 · decided 2007-06-11
Approval details
- PMA number
- P900009
- Supplement
- S025
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOGEN 4000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS)
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2007-02-22
- Decision date
- 2007-06-11
- Days to decision
- 109 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER OF THE EXTERNAL PLASTIC HOUSING FOR THE MAIN OPERATING UNIT. THIS INCLUDES THE TOP HOUSING, THE BOTTOM HOUSING, THE PUSH BUTTON AND THE LENS.
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