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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
Classification Namefull field digital,system,x-ray,mammographic
Generic Namefull field digital,system,x-ray,mammographic
Regulation Number892.1715
Applicant
SIEMENS MEDICAL SOLUTION
51 valley stream pkwy.
malvern, PA 19355
PMA NumberP030010
Supplement NumberS002
Date Received05/20/2005
Decision Date06/20/2005
Product Code
MUE[ Registered Establishments with MUE ]
Advisory Committee Radiology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
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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