PMA P110038S033

Device: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Applicant: Bolton Medical, Inc.
PMA number: P110038
Supplement: S033
Product code: MIH
Decision date: 2025-10-10
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: approval for labeling updates to include the final study results of the Relay Thoracic Stent-Graft with Plus Delivery System Pivotal, Continued Access, and Post Approval Studies

Current openFDA PMA Record#

Device: RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
Applicant: Bolton Medical, Inc.
PMA number: P110038
Supplement: S033
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2025-10-10
Decision code: APPR
Date received: 2025-04-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: approval for labeling updates to include the final study results of the Relay Thoracic Stent-Graft with Plus Delivery System Pivotal, Continued Access, and Post Approval Studies