• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceSelenia Dimensions 3D System High Resolution Tomosynthesis
Generic Namedigital breast tomosynthesis
Applicant
HOLOGIC, INC.
35 crosby dr.
bedford, MA 01730
PMA NumberP080003
Supplement NumberS008
Date Received04/04/2019
Decision Date10/24/2019
Product Code OTE 
Advisory Committee Radiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software option 3DQuoromTM technology, which generates thicker 6 mm slices (also referred as SmartSlices or slabs) and change to the indications for use statement as a result of this update.
-
-