• 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
Generic Namemr-guided focused ultrasound system
ApplicantInSightec
5 nahum heth street
tirat-hacarmet 39120
PMA NumberP150038
Supplement NumberS006
Date Received03/07/2018
Decision Date12/16/2018
Product Code POH 
Docket Number 19M-4780
Notice Date 01/25/2019
Advisory Committee Neurology
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Exablate Model 4000 (Neuro). The device is intended in the unilateral Thalamotomy (ventralis intermedius) treatment of Tremor-dominant Parkinson’s Disease with medication-refractory tremor. Patients must be at least age 30.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
-
-