PMA P110038S017

Device

Relay Thoracic Stent-Graft with Plus Delivery System

Applicant

Bolton Medical, Inc.

PMA number

P110038

Supplement

S017

Product code

MIH

Decision date

2018-02-06

Classification

System, Endovascular Graft, Aortic Aneurysm Treatment

Generic name

SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Approval order statement

Approval of the changes in the protocol to allow for completion of the postapproval study (PAS) protocol.

Summary

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