PMA P130021S102

Device: Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S102
Product code: NPT
Decision date: 2021-09-24
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval for modifications to the Instructions for Use to reflect the 5-year findings of the continued follow-up of premarket cohort post-approval studies.

Current openFDA PMA Record#

Device: Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S102
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2021-09-24
Decision code: APPR
Date received: 2021-07-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for modifications to the Instructions for Use to reflect the 5-year findings of the continued follow-up of premarket cohort post-approval studies.