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. |
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Device | TRANSCAN T-SCAN 2000 |
Generic Name | Imager, breast, electrical impedance |
Applicant | MIRABEL MEDICAL SYSTEMS, INC. 9020 North Capitol of Texas Highway Suite 250 Austin, TX 78759 |
PMA Number | P970033 |
Supplement Number | S002 |
Date Received | 06/15/1999 |
Decision Date | 05/03/2000 |
Product Code |
NCL |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
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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