PMA P130021S085

Device: Evolut PRO+ Transcatheter Aortic Valves of the Evolut PRO+ System
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S085
Product code: NPT
Decision date: 2021-02-26
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval for a modification to the polypropylene resin material formulation used in the packaging lid and retainer assembly.

Current openFDA PMA Record#

Device: Evolut PRO+ Transcatheter Aortic Valves of the Evolut PRO+ System
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S085
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2021-02-26
Decision code: APPR
Date received: 2021-02-12
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a modification to the polypropylene resin material formulation used in the packaging lid and retainer assembly.