EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM
FDA premarket approval P900009/S016 · decided 2003-02-21
Approval details
- PMA number
- P900009
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXOGEN 3000* LOW INTENSITY FRACTURE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2002-12-20
- Decision date
- 2003-02-21
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR CHANGES TO THE EXOGEN 3000* LABELING IN ORDER THAT IT MORE CLOSELY RESEMBLE THE APPROVED LABELING FOR THE EXOGEN 2000+*.
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