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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 NameSIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital mammography system
Regulation Number892.1715
ApplicantSIEMENS MEDICAL SOLUTION
PMA NumberP030010
Supplement NumberS002
Date Received05/20/2005
Decision Date06/20/2005
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling changes to the operators manual which add or strengthen a contraindication, warning, precaution, or information about an adverse reaction and add or strengthen an instruction that is intended to enhance the safe use of the device.
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