PRAKTIS
FDA premarket approval P950014/S011 · decided 1998-03-13
Approval details
- PMA number
- P950014
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PRAKTIS
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, Inc.
- Date received
- 1997-12-31
- Decision date
- 1998-03-13
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- 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 ava
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