EXOGEN 4000+BONE HEALING SYSTEM
FDA premarket approval P900009/S029 · decided 2008-12-18
Approval details
- PMA number
- P900009
- Supplement
- S029
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOGEN 4000+BONE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2008-11-28
- Decision date
- 2008-12-18
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL TO CHANGE THE LOCATION OF THE DISTRIBUTION AND STORAGE FACILITIES TO A FACILITY IN MEMPHIS, TENNESSEE.
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