PMA P130021S187

Device: Medtronic Evolut FX Delivery Catheter System; EvolutTranscatheter Aortic Valve System
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S187
Product code: NPT
Decision date: 2026-08-10
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: to introduce an alternative supplier for a component of the Evolut FX delivery catheter system

Current openFDA PMA Record#

Device: Medtronic Evolut FX Delivery Catheter System; EvolutTranscatheter Aortic Valve System
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S187
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-08-10
Decision code: OK30
Date received: 2026-07-16
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to introduce an alternative supplier for a component of the Evolut FX delivery catheter system