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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NamePRAKTIS
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nameprostate (bph) microwave apparatus
ApplicantEDAP TECHNOMED, INC.
PMA NumberP950014
Supplement NumberS011
Date Received12/31/1997
Decision Date03/13/1998
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new hardware and software configuration of the prostatron(tm). The device, as modified, will be marketed under the trade name prostatron(tm) praktis and is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (turp) for the treatment of symptomatic benign prostatic hyperplasia (bph). It is intended that the prostatron(tm) praktis deliver a complete thermal therapy treatment during a single treatment session. The prostatron(tm) praktis is available with two treatment protocols, each requiring a unique treatment catheter. Protocol 2. 0, which uses the standard prostaprobe (black) treatment catheter, is indicated for patients with prostatic lengths of 35 to 50 mm. The higher energy protocol 2. 5, which uses the prostaprobe (blue) treatment catheter, is indicated for patients with prostatic lengths of 25 to 50 mm in whom the benefits of obstructive improvement outweigh the attendant risks.
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