EXOGEN BONE HEALING SYSTEM 2000 ,3000
FDA premarket approval P900009/S021 · decided 2008-12-19
Approval details
- PMA number
- P900009
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXOGEN BONE HEALING SYSTEM 2000 ,3000
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2005-08-01
- Decision date
- 2008-12-19
- Days to decision
- 1236 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR LABELING MODIFICATIONS AIMED TO SIMPLIFY THE DEVICE LABELING.
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| MCS Bone Graft (K162860) | Bioventus, LLC | 2017-02-13 |