PROSTATRON

FDA premarket approval P950014 · decided 1996-05-03

Approval details

PMA number: P950014
Trade name: PROSTATRON
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant: Urologix, Inc.
Date received: 1995-04-17
Decision date: 1996-05-03
Days to decision: 382 days
Decision code: APWD
Product code: MEQ
Advisory committee: Gastroenterology, Urology
Expedited review: Yes
Location: Plymouth, MN
Statement: APPROVAL FOR PROSTATRON

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510(k) clearances by this applicant

Record	Firm	Date
Prostiva RF Therapy Generator, Prostiva RF Therapy Hand Piece, Prostiva RF Therapy Return Electrode, Prostiva RF Therapy Tubing System, Prostiva RF Therapy Telescope (K142248)	Urologix, Inc.	2015-02-20