Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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.
 
DeviceSoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface
Generic NameAutomated breast ultrasound
ApplicantDelphinus Medical Technologies
45525 Grand River Ave.
Novi, MI 48374
PMA NumberP200040
Supplement NumberS001
Date Received05/30/2023
Decision Date04/11/2024
Product Code PAA 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site change to Delphinus Medical Technologies, Inc., 45525 Grand River Ave, Suite 100, Novi, MI 48374-1308.
-
-