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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM
Generic NameSystem, imaging, pulsed doppler, ultrasonic
Regulation Number892.1550
ApplicantADVANCED TECHNOLOGY LABORATORIES, INC.
22100 BOTHELL EVERETT HWY.
P.O. BOX 3003
BOTHELL, WA 98041-3003
PMA NumberP940005
Date Received02/17/1994
Decision Date04/11/1996
Withdrawal Date 05/04/2009
Product Code IYN 
Docket Number 96M-0450
Notice Date 11/29/1996
Advisory Committee Radiology
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ULTRAMARK 9 HIGH DEFINITION IMAGING (HDI) ULTRASOUND SYSTEM WITH L10-5 SCANHEAD
Supplements:  S001 S002 
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