FDA.reportPublic FDA data

PMA P130021S075

Device
CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV)
Applicant
Medtronic, Inc.
PMA number
P130021
Supplement
S075
Product code
NPT
Decision date
2020-05-05
Generic name
Aortic valve, prosthesis, percutaneously delivered
Approval order statement
Implementation of a new serial tag printer, a serial tag printing sequence change, and a new vision system for an additional inspection used in the manufacturing of CoreValve Evolut R, CoreValve Evolut PRO, and Evolut PRO+ systems.

Current openFDA PMA Record#

Device
CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV)
Applicant
Medtronic, Inc.
PMA number
P130021
Supplement
S075
Product code
NPT
Generic name
Aortic valve, prosthesis, percutaneously delivered
Decision date
2020-05-05
Decision code
OK30
Date received
2020-04-30
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a new serial tag printer, a serial tag printing sequence change, and a new vision system for an additional inspection used in the manufacturing of CoreValve Evolut R, CoreValve Evolut PRO, and Evolut PRO+ systems.