PMA P970008S001

Device: UROLOGIX TARGIS SYSTEM
Applicant: Urologix, LLC
PMA number: P970008
Supplement: S001
Product code: MEQ
Decision date: 1997-08-28
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: Approval for a change in trade name. The device will be marketed under the trade anme Urologix Targis(TM) system and is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) in ment with prostatic lengths of 30 to 50 millimeters.

Current openFDA PMA Record#

Device: UROLOGIX TARGIS SYSTEM
Applicant: Urologix, LLC
PMA number: P970008
Supplement: S001
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 1997-08-28
Decision code: APPR
Date received: 1997-08-26
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a change in trade name. The device will be marketed under the trade anme Urologix Targis(TM) system and is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) in ment with prostatic lengths of 30 to 50 millimeters.