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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.
 
DeviceTS2000
Generic NameImager, breast, electrical impedance
ApplicantMIRABEL MEDICAL SYSTEMS, INC.
9020 North Capitol of Texas Highway
Suite 250
Austin, TX 78759
PMA NumberP970033
Supplement NumberS001
Date Received06/23/1999
Decision Date11/15/1999
Product Code NCL 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes in the electronic circuitry, elimination of all but the 200 Hz frequency, optional small probe, and optional phantom. The device is intended for use as an adjunct to mammography in patients who have equivocal mammographic findings within ACR BI-RADS(TM) categories 3 or 4. In particular, it is not intended for use in cases with clear mammographic or non-mammographic indications for biopsy. This device provides the radiologist with additional information to guide a biopsy recommendation.
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