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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 NameTRANSCAN T-SCAN 2000
Classification Nameimager, breast, electrical impedance
ApplicantMIRABEL MEDICAL SYSTEMS, INC.
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 pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
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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