• 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 NamePROSTALUND CORETHERM SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave/thermal therapy system
ApplicantPROSTALUND AB
PMA NumberP010055
Supplement NumberS007
Date Received09/09/2009
Decision Date01/29/2014
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the indications for use and associated modifications to the catheter, antenna, and temperature probe for patients with prostates smaller than currently indicated. The device, as modified, will be marketed under the trade name coretherm accessories for small prostates and is indicated for use together with prostalund coretherm /se in patients with glands size 20-50g and with a prostate length ¿25 mm.
-
-