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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.
 
DeviceTRANSCAN T-SCAN 2000
Generic NameImager, breast, electrical impedance
ApplicantMIRABEL MEDICAL SYSTEMS, INC.
9020 North Capitol of Texas Highway
Suite 250
Austin, TX 78759
PMA NumberP970033
Supplement NumberS002
Date Received06/15/1999
Decision Date05/03/2000
Product Code NCL 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of a protocol for a postapproval study to examine the effects of the mentrual cycle on the results of the device.
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