Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | PROSTATRON PRAKTIS |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Urologix, Inc. 14405 21ST AVENUE N. MINNEAPOLIS, MN 55447-2000 |
PMA Number | P950014 |
Supplement Number | S022 |
Date Received | 05/17/2004 |
Decision Date | 06/10/2004 |
Withdrawal Date
|
12/30/2014 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR DESIGN CHANGES TO INCLUDE CHANGING THE CONTACTS ON THE INTERNAL WIRING FROM TIN TO GOLD AND A MODIFICATION TO THE SOFTWARE TO INCLUDE AN ADDITIONAL ALARM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROSTATRON PRAKTIS AND IS INDICATED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). |
|
|