PMA P130021S096

Device: Medtronic CoreValve™ Evolut™ R Transcatheter Aortic Valve, Medtronic CoreValve™ Evolut™ Pro Transcatheter Aortic Valve,
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S096
Product code: NPT
Decision date: 2021-06-17
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Relocation of tissue processing worksteps to new controlled environments including introduction of new equipment, systems, and layout changes.

Current openFDA PMA Record#

Device: Medtronic CoreValve™ Evolut™ R Transcatheter Aortic Valve, Medtronic CoreValve™ Evolut™ Pro Transcatheter Aortic Valve,
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S096
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2021-06-17
Decision code: OK30
Date received: 2021-05-18
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Relocation of tissue processing worksteps to new controlled environments including introduction of new equipment, systems, and layout changes.