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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 N. Capitol Of Texas Hwy.
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
Predetermined Change Control Plan AuthorizedNo
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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