PMA P970008S006

Device: UROLOGIC TARGIS SYSTEM
Applicant: Urologix, LLC
PMA number: P970008
Supplement: S006
Product code: MEQ
Decision date: 1998-07-27
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: Approval for an expansion of the indication for use statement to include relief o obstruction. The indication for use, as modified, is "The Urologix Targis System is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethra lengths of 30 to 50 mm.

Current openFDA PMA Record#

Device: UROLOGIC TARGIS SYSTEM
Applicant: Urologix, LLC
PMA number: P970008
Supplement: S006
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 1998-07-27
Decision code: APPR
Date received: 1998-05-05
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for an expansion of the indication for use statement to include relief o obstruction. The indication for use, as modified, is "The Urologix Targis System is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethra lengths of 30 to 50 mm.