• 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
Classification Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Generic Nameablation system, high intensity focused ultrasound (hifu), mr-guided
Applicant
INSIGHTEC, LTD
4851 lbj frwy, ste 400
dallas, TX 75244
PMA NumberP040003
Supplement NumberS010
Date Received09/13/2011
Decision Date12/08/2011
Product Code
NRZ[ Registered Establishments with NRZ ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MODIFICATION OF THE EXABLATE PLATFORM 1) SO THAT THE SAME PLATFORM CAN BE USED WITH MULTIPLE CRADLES; AND 2) TO ENABLE THE CRADLE THAT HAS THE CAPABILITY TO MOVE THE TRANSDUCER IN THE ANTERIOR AND POSTERIOR DIRECTIONS BE USED IN THE LOCKED POSITION FORCOMMERCIAL UTERINE FIBROID TREATMENT.
-
-