• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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 NameHYDRO THERMABLATOR. ENDOMETRIAL ABLATION SYSTEM
Classification Namedevice, thermal ablation, endometrial
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP000040
Supplement NumberS002
Date Received10/09/2001
Decision Date12/07/2001
Product Code
MNB[ Registered Establishments with MNB ]
Advisory Committee Obstetrics/Gynecology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for using molding and extruding techniques rather than machining the components that nmake up the disposable sheath of the hydro thermablator endometrial ablation system.
-
-