EXOGEN 4000+
FDA premarket approval P900009/S032 · decided 2010-03-26
Approval details
- PMA number
- P900009
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOGEN 4000+
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2010-02-24
- Decision date
- 2010-03-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- COMPONENT MANUFACTURER SITE CHANGE.
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510(k) clearances by this applicant
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|---|---|---|
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| SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty (K233490) | Bioventus, LLC | 2023-12-05 |
| MCS Bone Graft (K162860) | Bioventus, LLC | 2017-02-13 |