UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

FDA premarket approval P970008/S025 · decided 2005-02-15

Approval details

PMA number

P970008

Supplement

S025

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH

Generic name

System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy

Applicant

Urologix, LLC

Date received

2005-02-01

Decision date

2005-02-15

Days to decision

14 days

Decision code

APPR

Product code

MEQ

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Plymouth, MN

Statement

APPROVAL FOR THE FOLLOWING CHANGES TO THE DEVICE: 1) THE CHANGE OF THE INSERTION TIP AND ADHESIVE OF THE COOLED THERMOCATH MICROWAVE DELIVERY SYSTEM (CTC MDS) TO INCREASE TO THE FLEXIBILITY OF THE CATHETER; 2) THE CHANGE OF THE INSERTION TIP AND ADHESIVE OF THE TARGIS MICROWAVE DELIVERY SYSTEM TO THE SAME CATHETER TYPE AS THE CTC MDS; AND 3) THE ADDITION OF TEXIN 950 UV STABILIZED TUBING FOR THE SHAFT OF THE CTC CATHETER.