System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Basic Information
- Device Name
- System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
- Trade Name
- PRAKTIS
- PMA Number
- P950014
- Supplement Number
- S011
- Device Class
- FDA Class 3
- Product Code
- MEQ
- Generic Name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Medical Specialty
- Unknown
- Advisory Committee
- Gastroenterology, Urology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 13, 1998
- Date Received
- December 31, 1997
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MEQ | System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy | FDA class 3 | Unknown |