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 | MAMMOMAT Revelation with Tomosynthesis Option System |
Generic Name | Digital breast tomosynthesis |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. MALVERN, PA 19355-1406 |
PMA Number | P140011 |
Supplement Number | S007 |
Date Received | 01/29/2020 |
Decision Date | 08/21/2020 |
Product Code |
OTE |
Advisory Committee |
Radiology |
Clinical Trials | NCT01373671
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for 1) a new processing scheme for synthetic mammograms (new Insight 2D/3D), and 2) an updated Indications for Use to include Digital Breast Tomosynthesis (DBT) in combination with synthesized image sets, Insight 2D, or Insight 2D and Insight 3D, as a screening mode, for MAMMOMAT Revelation with Tomosynthesis Option. |
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