PMA P110038S013

Device: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Applicant: Bolton Medical, Inc.
PMA number: P110038
Supplement: S013
Product code: MIH
Decision date: 2017-03-23
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for the ability to remove the Relay Thoracic Stent Graft from a non-conforming device and load the implant into a new delivery system.

Current openFDA PMA Record#

Device: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Applicant: Bolton Medical, Inc.
PMA number: P110038
Supplement: S013
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2017-03-23
Decision code: APPR
Date received: 2016-08-29
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the ability to remove the Relay Thoracic Stent Graft from a non-conforming device and load the implant into a new delivery system.