• 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 NamePROSTATRON MAXIS
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nameprostate (bph) microwave apparatus
ApplicantEDAP TECHNOMED, INC.
PMA NumberP950014
Supplement NumberS012
Date Received01/14/1998
Decision Date01/22/1998
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new trade name for the single-module configuration of the prostatron. The device will be marketed under the trade name prostatron maxis and is indicated for the treatment of symptomatic benign prostatic hyperplasia (bph).
-
-