Lot Numbers: 58294818, 58306516, 58311615, 58337133, 58338748, 58404088, 58410765, 58419031, 58432230, FR6J0217, and FR6J0234

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060803CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: FR6J0251, and FR6K0315

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: 58294838, FR6H0158,  FR6K0288,  FR6K0325,  R58274189, R58279729, FR6K0279, and FR6K0335

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: FR6H0150,  FR6K0271A,  FR6K0326,  R58279730, and R58308182

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: FR6H0156  FR6H0209  FR6K0304  R58283591 and R58286397

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: 58289990, 58298661, FR6H0181,  FR6J0218,  FR6J0235,  FR6K0327, and FR6K0348

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070403CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: R58270989, R58284563, R58285860, R58293765, FR6J0244, and FR6K0336

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070601CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: R58289766, R58289767, R58293038, R58295135, R58301758, 58315414, 58325057, 58407270, 58412480, 58419033, 58430096, RFR6J0219, and FR6K0328

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070603CD

Lot Numbers: 58298658, 58406012, RFR6J0257,  FR6K0284, and  FR6K0316

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070801CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: R58279091, 58288280, 58289993, 58290196, 58308185, R58321778, 58401900, 58410766, 58432236, 58437453, FR6J0238, and  RFR6J0263

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070803CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: FR6J0252,  FR6K0342, and FR6K0347

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: 58266138, 58274193, FR6J0266,  FR6K0308, and FR6L0349

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: FR6J0258, and FR6K0337

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: 58289994, FR6J0267,  FR6K0287,  FR6K0309, and  FR6K0339

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: 58316534, FR6J0261,  FR6K0282,  FR6K0317,  R58266135, R58280596, and R58285861

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: FR6H0214, and RFR6J0220

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080403CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: R58266137, R58279720, R58296523, 58325045, 58406018, 58410764, 58415739, FR6H0210,  FR6K0293, RFR6K0297, and RFR6K0318

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080601CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: R58280597, 58289995, 58316538, 58412483, 58425340, 58435212, FR6J0268, and  RFR6K0329

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080603CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: 58266130, 58285862, R58315409, B58433721, FR6J0259, and FR6K0285

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080801CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: R58274194, R58279723, R58279092, 58315415, 58338578, 58346286, 58423554, FR6J0265,  FR6K0310, and FR6K0334

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080803CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: 58266133, FR6H0187, and  FR6J0245

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090201CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Number FR6K0275

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090203CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: FR6H0169,  FR6J0227, and FR6K0320

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090301CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: 58266279, FR6H0184, and FR6K0290

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090303CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Lot Numbers: FR6H0142,  FR6J0246,  FR6K0321, and R58301781

Gastroenterology-Urology Devices

2

Yes

Nationwide

Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090401CD. The LifeStent FlexStar self-expanding biliary stent system is intended for use in the palliation of malignant strictures (neoplasms) in the biliary tree.