Urologix, Inc.

Serial numbers PP80023 through PP80040 and PP037 through PP180

Gastroenterology-Urology Devices

3

No

The product was shipped to consignees located nationwide in the United States and to foreign consignees in Australia, France and Japan.

Prostatron Praktis Type II for Transurethral Microwave Thermotherapy. The Prostatron is a computer-controlled device designed to deliver microwave energy to the prostrate for the treatment of BPH (Benign Prostatic Hyperplasia). The Prostatron utilizes a transurethral microwave antenna, with simultaneous urethral cooling, to heat the prostate. This heating process is regulated through feedback from a series of temperature sensors.

Catalog # / Lot No.  PT1034 / AHP0333111A, AHP040411A, AHP040411B, AHP040611A, AHP040711A, AHP040811A, AHP041211A  PT1036 / ACP033011B, ACP040111A, ACP040111B, ACP040611A, ACP040711A, ACP040711B, ACP040811A, ACP041211A  PT1038 / ALP033111A, ALP040411A  PT1013 / KP040711A  CA1111B / C900284, C900285 and C900286  C900284, C900285 and C900286  C900284 and C900285  C900285

Gastroenterology-Urology Devices

3

No

Nationwide Distribution--including the states of AL, CA, CO, FL, GA, MA, MI, MN, NJ, NY, OR, PA, TN, WV, and including Puerto Rico.

The following kits contain the UROLOGIX, Coolant Bag, CA1111B, Sterile EO, Manufactured for: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || UROLOGIX, CTC Advance Short, (2.5-3.5 cm), PT1034, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || CTC Advance Standard , (3.0-5.0 cm), PT1036, Sterile EO,, Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || CTC Advance Long, (4.5+ cm), PT1038, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || Targis Standard, (3.0-5.0 cm), PT1013, Sterile EO,Manufactured by: UROLOGIX, Inc., 14405 Twenty-first Avenue North, Minneapolis, MN 55447. || 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 urethral lengths greater than 2.5 cm.

Individual Catheter lot numbers: M002671,M002672, M002589 and M002736 for model TA1121D.  Kit box lot numbers: KP011206, KP053006B, KP053006C, KP060205, KP0011206.

Gastroenterology-Urology Devices

3

No

Nationwide and the Netherlands.

Urologix Microwave Delivery System 3.0 - 5.0. For use with prostatic urethra lengths of 3.0-5.0 cm only. Model TA1121D.

Individual catheter lot number KG001346 for model TA1321D. Kit box lot number KGP111105.

Gastroenterology-Urology Devices

3

No

Nationwide and the Netherlands.

Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D.

KIT LOT NUMBER:  ACP011610D, ACP011710E, ACP011810F, ACP011910G, AHP01810D, AHP011210A, AHP011310B, AHP012310C, AHP012510C, AHP012710C, ALP012510B, and RH00252  CATHETER LOT NUMBERS:  091226MCA1, 091228MHA1, 091229MCA1, 091229MCA2, 091229MHA1, 09123MCA1, 091230MHA1, 100105MHA1, 100106MHA1, 100106MHA2, 100111MHA1, 100111MHA2, 100111MHA3, 100112MLA2, 100113MHA1, 100113MHA2, and 100114MHA1  RTU PLUS LOT NUMBERS:  Handle =RH00252, Balloon= RB0781 & RB0783

Gastroenterology-Urology Devices

3

No

AL, AZ, CA, FL, IN, MI, MN, MS, NY, OK PA, TN, TX, and WI.

UROLOGIX¿ CTC Advance" Standard Microwave Catheter (3.0-5.0 cm), CTC Advance" Long Microwave Catheter (4.5+ cm), CTC Advance" Short Microwave Catheter (2.5 -3.5 cm), RTU Plus Balloon, and RTU Plus Handle, Sterile EO, Manufactured by UROLOGIX¿, INC, 14405 Twenty-First Avenue North, Minneapolis, MN 55447. || The CTC Advance" catheters and RTU Plus are used as part of the Targis¿ System. || Each disposable device is packaged on a card inside a heat sealed pouch. Each Kit Box then hold 3 product pouches: 1 catheter, 1 coolant bag and 1 RTU Plus balloon. The RTU Plus Kit contains 3 RTU Plus Handles packaged in separate sterile pouches.