PMA P130021S183

Device: Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S183
Product code: NPT
Decision date: 2026-02-10
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: changes to the layout, monitoring, and capacity of controlled environment areas

Current openFDA PMA Record#

Device: Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve; Medtronic Evolut™ PRO+ Transcatheter Aortic Valve; Medtroni
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S183
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-02-10
Decision code: OK30
Date received: 2026-02-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: changes to the layout, monitoring, and capacity of controlled environment areas