PMA P130021

Device: Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System; Medtronic Evolut FX Transcatheter Aortic Valve Repl
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S131
Product code: NPT
Decision date: 2026-07-14
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval for various modifications to the device labeling regarding alternate access routes for valve delivery.

Current openFDA PMA Record#

Device: Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System; Medtronic Evolut FX Transcatheter Aortic Valve Repl
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S185
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-07-14
Decision code: APPR
Date received: 2026-04-15
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for various modifications to the device labeling regarding alternate access routes for valve delivery.