PMA P130021S180

Device: Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S180
Product code: NPT
Decision date: 2026-02-04
Classification: Cardiovascular
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: an alternative batch testing plan for bacterial endotoxin testing

Current openFDA PMA Record#

Device: Medtronic CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S180
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2026-02-04
Decision code: OK30
Date received: 2026-01-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative batch testing plan for bacterial endotoxin testing