EXOGEN 2000+ BONE HEALING SYSTEM
FDA premarket approval P900009/S023 · decided 2006-06-30
Approval details
- PMA number
- P900009
- Supplement
- S023
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOGEN 2000+ BONE HEALING SYSTEM
- Generic name
- Stimulator, ultrasound and muscle, for use other than applying therapeutic deep
- Applicant
- Bioventus, LLC
- Date received
- 2006-05-15
- Decision date
- 2006-06-30
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- APPROVAL FOR THE INCORPORATION OF A DRI-SHIELD 2000 MOISTURE BARRIER BAG (ELECTROSTATIC DISCHARGE [ESD] BAG) AS PART OF THE DEVICE PACKAGING.
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