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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 Namestimulator, ultrasound and muscle, for use other than applying therapeutic deep
ApplicantBIOVENTUS LLC
PMA NumberP900009
Supplement NumberS018
Date Received01/29/2004
Decision Date03/12/2004
Product Code
LPQ[ Registered Establishments with LPQ ]
Advisory Committee Physical Medicine
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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