PMA P950014S011
- Device
- PRAKTIS
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S011
- Product code
- MEQ
- Decision date
- 1998-03-13
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- 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.
Current openFDA PMA Record#
- Device
- PRAKTIS
- Applicant
- Urologix, Inc.
- PMA number
- P950014
- Supplement
- S011
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1998-03-13
- Decision code
- APPR
- Date received
- 1997-12-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.