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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameEXOGEN 2000+ AND EXOGEN 3000
Classification Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
Generic Namelow-intensity pulsed ultrasonic device for the treatment on nonunion
ApplicantSMITH & NEPHEW, INC.
PMA NumberP900009
Supplement NumberS018
Date Received02/04/2004
Decision Date03/12/2004
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two design and component changes: 1) changes to exogen 2000+ printed circuit board to implement corrective action for field failure and returns. This corrective action involves two design changes: i) replace 2 diodes on te printed circuit board with light emitting diodes. Ii) add a 1000 pf capacitor to reduce electrical noise. 2) replace both exogen 2000+ and exogen 3000 transducer cables with a more cost effective model.
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