FDA.reportPublic FDA data

PMA P130021S104

Device
Medtronic CoreValve™ Evolut™ R Transcatheter Aortic Valve, Medtronic CoreValve™ Evolut™ Pro Transcatheter Aortic Valve,
Applicant
Medtronic, Inc.
PMA number
P130021
Supplement
S104
Product code
NPT
Decision date
2021-10-21
Generic name
Aortic valve, prosthesis, percutaneously delivered
Approval order statement
Approval for updates regarding flush port orientation, handle rotation, and valve deployment/retrieval timing to the Evolut R, Evolut PRO, and Evolut PRO+ Instructions for Use (IFU) to align to physician training materials and risk documentation.

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
S104
Product code
NPT
Generic name
Aortic valve, prosthesis, percutaneously delivered
Decision date
2021-10-21
Decision code
APPR
Date received
2021-09-22
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for updates regarding flush port orientation, handle rotation, and valve deployment/retrieval timing to the Evolut R, Evolut PRO, and Evolut PRO+ Instructions for Use (IFU) to align to physician training materials and risk documentation.