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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
Generic Namethermal endometrial ablation device
ApplicantHOLOGIC, INC.
PMA NumberP010013
Supplement NumberS024
Date Received06/30/2009
Decision Date07/31/2009
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes intended to improve the instructions for use by adding a contraindication for use in patients with a metal object in the uterus or uterine cavity.
-
-