FDA.reportPublic FDA data

PMA P130021S081

Device
EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, EnVeo PRO Lo
Applicant
Medtronic, Inc.
PMA number
P130021
Supplement
S081
Product code
NPT
Decision date
2020-10-30
Generic name
Aortic valve, prosthesis, percutaneously delivered
Approval order statement
Changes to the acceptance criteria for the temperature probes during product parameter profile studies conducted during requalification of the sterilization cycle.

Current openFDA PMA Record#

Device
EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, EnVeo PRO Lo
Applicant
Medtronic, Inc.
PMA number
P130021
Supplement
S081
Product code
NPT
Generic name
Aortic valve, prosthesis, percutaneously delivered
Decision date
2020-10-30
Decision code
OK30
Date received
2020-10-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Changes to the acceptance criteria for the temperature probes during product parameter profile studies conducted during requalification of the sterilization cycle.