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 2000/2100 1.5 AND 3T
Generic NameAblation system, high intensity focused ultrasound (HIFU), MR-guided
ApplicantINSIGHTEC, LTD
4851 LBJ FRWY, STE 400
DALLAS, TX 75244
PMA NumberP040003
Supplement NumberS009
Date Received07/26/2010
Decision Date08/09/2011
Product Code NRZ 
Advisory Committee Obstetrics/Gynecology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR UPDATED LABELING INCLUDING LONG-TERM DATA FROM THE POST-APPROVAL STUDY.
-
-