FDA.reportPublic FDA data

PMA P130021S077

Device
Evolut R, Evolut PRO and Evolut PRO+ Transcatheter Aortic Valves (TAV)s
Applicant
Medtronic, Inc.
PMA number
P130021
Supplement
S077
Product code
NPT
Decision date
2020-06-11
Generic name
Aortic valve, prosthesis, percutaneously delivered
Approval order statement
Manufacturing site addition for the supplier of the primary packaging component for the Evolut R, Evolut PRO, and Evolut PRO+ Transcatheter Aortic Valves.

Current openFDA PMA Record#

Device
Evolut R, Evolut PRO and Evolut PRO+ Transcatheter Aortic Valves (TAV)s
Applicant
Medtronic, Inc.
PMA number
P130021
Supplement
S077
Product code
NPT
Generic name
Aortic valve, prosthesis, percutaneously delivered
Decision date
2020-06-11
Decision code
OK30
Date received
2020-05-22
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Manufacturing site addition for the supplier of the primary packaging component for the Evolut R, Evolut PRO, and Evolut PRO+ Transcatheter Aortic Valves.