GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

FDA premarket approval P040043/S124 · decided 2021-03-25

Approval details

PMA number

P040043

Supplement

S124

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Applicant

W. L. Gore & Associates, Inc.

Date received

2021-02-23

Decision date

2021-03-25

Days to decision

30 days

Decision code

OK30

Product code

MIH

Advisory committee

Cardiovascular

Expedited review

No

Location

Flagstaff, AZ

Statement

implementation of an FEP formulation change by a sub-tier supplier in the manufacturing of Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG Device), GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL SYSTEM (CMDS Device) and GORE® EXCLUDER® Iliac Branch Endoprosthesis Iliac Bifurcated Component (IBE IBC Device).

510(k) clearances by this applicant