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.
 
DeviceEXABLATE SYSTEM
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantInsightec, Ltd.
4851 Lbj Frwy
Suite 400
Dallas, TX 75244
PMA NumberP040003
Supplement NumberS012
Date Received08/13/2012
Decision Date09/07/2012
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING OF THE TRANSDUCER FOR THE EXABLATE SYSTEM FROM A CONTRACT MANUFACTURER TO THE IN-HOUSE FACILITY.
-
-