PMA P110038S018

Device: Relay Thoracic Stent-Graft with Plus Delivery System
Applicant: Bolton Medical, Inc.
PMA number: P110038
Supplement: S018
Product code: MIH
Decision date: 2018-06-15
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for minor updates to the drawing and associated manufacturing and quality procedures for the delivery system constraining sleeve.

Current openFDA PMA Record#

Device: Relay Thoracic Stent-Graft with Plus Delivery System
Applicant: Bolton Medical, Inc.
PMA number: P110038
Supplement: S018
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2018-06-15
Decision code: APPR
Date received: 2018-05-17
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for minor updates to the drawing and associated manufacturing and quality procedures for the delivery system constraining sleeve.