EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND EXOGEN 3000 SONIC ACCELERATED FRACTURE HEALING SYSTEM
FDA premarket approval P900009/S020 · decided 2005-05-19
Approval details
- PMA number
- P900009
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EXOGEN 2000+ SONIC ACCELERATED FRACTURE HEALING SYSTEM (SAFHS) AND 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
- 2005-04-29
- Decision date
- 2005-05-19
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LPQ
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Durham, NC
- Statement
- ADDITION OF A NEW CONTRACT VENDOR FOR THE SUPPLY OF COMPONENTS/ MATERIALS USED IN THE MANUFACTURING PROCESS.
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