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 | PROMINENT CALC FEATURE MARKER |
Generic Name | Analyzer, medical image |
Regulation Number | 892.2070 |
Applicant | HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 |
PMA Number | P970058 |
Supplement Number | S009 |
Date Received | 12/08/2000 |
Decision Date | 01/22/2001 |
Reclassified Date
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02/21/2020 |
Product Code |
MYN |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF A NEW CALCIFICATION MARKER. THIS MARKER (A CIRCLE) IS INTENDED TO ENABLE THE USER OF THE IMAGECHECKER TO DIFFERENTIATE OBVIOUS CALCIFICATIONS FROM MORE SUBTLE CALCIFICATIONS THAT APPEAR IN ANALYZED MAMMOGRAMS. |
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