Protg

Lot # 9922795

Cardiovascular Devices

3

Yes

International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.

ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

Lot # 9922452

Cardiovascular Devices

3

Yes

International Only Distribution -- RUSSIA, ROMANIA, UNITED KINGDOM, GERMANY, ITALY, SPAIN, FRANCE, TURKEY, POLAND, and JAPAN.

ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, Rx only. || Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require percutaneous carotid revascularization and meet outlined criteria.

Lot 2675311

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution --- state of LA.

Ev3 Protege GPS Biliary Stent Systems || 6 mm, 60 mm, 120cm, .35, 6Fr, OTW || Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 || REF SERB65-06-60-120 || Lot 2675311 || Use before 2009-01-01 || Sterile EO || Intended as a palliative treatment of malignant neoplasms in the biliary tree.

Lot 2092998

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution --- state of NJ

Ev3 Primus GPS Biliary Stent System || 8 mm, 37 mm, B7, .40 mm, 5Fr, || REF BXB35-08-37-75 || Use before 2009-02 || Sterile EO || Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 || Intended as a palliative treatment of malignant neoplasms in the biliary tree.

Lot Numbers: 7857377, 7856788 and 7858698.

Gastroenterology-Urology Devices

2

Yes

Nationwide Distribution -- CA, FL, IL, LA, MA, MI, NH, PA, TN, TX, UT, VA and WA.

ev3 Prot¿g¿ EverFlex Self-Expanding Biliary Stent System, Sterile EO, (REF: PRB35-06-150-080, REF PRB35-06-120-120 and PRB35-06-150-120), 4.5 - 5.5mm, Expiration: 2011-10-01, Rx only. ev3 Inc., 4500 Nathan Lane North, Plymouth, MN 55442-2929. || Intended as a palliative treatment of malignant neoplasms in the biliary tree.