EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM
FDA premarket approval P900009/S014 · decided 2002-11-18
Approval details
- PMA number
- P900009
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2001-12-07
- Decision date
- 2002-11-18
- Days to decision
- 346 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR LABELING CHANGES TO THE PHYSICIAN'S INSTRUCTIONS FOR USE.
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