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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.
 
DeviceSECOND LOOK
Classification Nameanalyzer,medical image
Generic Nameanalyzer,medical image
Applicant
ICAD, INC.
98 spit brook road
suite 100
nashua, NH 03062
PMA NumberP010038
Supplement NumberS010
Date Received10/18/2005
Decision Date01/13/2006
Product Code
MYN[ Registered Establishments with MYN ]
Advisory Committee Radiology
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at infumedics, inc. , east walpole, massachusetts.
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