PMA P040043S105

Device

GORE Conformable TAG Thoracic Endoprosthesis

Applicant

W. L. Gore & Associates, Inc.

PMA number

P040043

Supplement

S105

Product code

MIH

Decision date

2018-10-17

Classification

System, Endovascular Graft, Aortic Aneurysm Treatment

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Approval order statement

Implement an additional film attach machine to be used during the manufacture of the GORE Conformable TAG Thoracic Endoprosthesis.

Summary

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