FDA.reportPublic FDA data

PMA P110038S016

Device
RelayPlus Thoracic Stent-Graft System
Applicant
Bolton Medical, Inc.
PMA number
P110038
Supplement
S016
Product code
MIH
Decision date
2017-12-08
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for updates to the Instructions for Use including clarifications regarding device deployment directions, as well as other minor administrative and editorial changes.

Current openFDA PMA Record#

Device
RelayPlus Thoracic Stent-Graft System
Applicant
Bolton Medical, Inc.
PMA number
P110038
Supplement
S016
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2017-12-08
Decision code
APPR
Date received
2017-11-17
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for updates to the Instructions for Use including clarifications regarding device deployment directions, as well as other minor administrative and editorial changes.