EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
FDA premarket approval P900009/S012 · decided 2001-02-21
Approval details
- PMA number
- P900009
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Trade name
- EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2000-10-12
- Decision date
- 2001-02-21
- Days to decision
- 132 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR A CHANGE IN LABELING FOR THE EXOGEN 3000(R), TO INCORPORATE BOTH THE FRESH FRACTURE AND NONUNION INFORMATION INTO ONE SET OF PHYSICIAN'S INSTRUCTIONS FOR USE, PATIENT'S INSTRUCTIONS FOR USE, AND PRODUCT INSERT BULLETIN; TO MAKE MANUAL SIZE AND FORMATTING CHANGES, AND TO ADD NONUNION BACKGROUND INFORMATION.
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