PMA P130021S103

Device: Evolut FX device
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S103
Product code: NPT
Decision date: 2021-09-22
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: The following changes implemented to Evolut FX: 1) relocation of tissue processing worksteps to new controlled environments including introduction of new equipment, systems, and layout changes; 2) implementation of new equipment and process re-sequencing for a delivery catheter system component; 3) dimensional modifications to a measurement tool used for in-process inspection of the delivery catheter; and 4) addition of a new tissue supplier.

Current openFDA PMA Record#

Device: Evolut FX device
Applicant: Medtronic, Inc.
PMA number: P130021
Supplement: S103
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2021-09-22
Decision code: OK30
Date received: 2021-09-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The following changes implemented to Evolut FX: 1) relocation of tissue processing worksteps to new controlled environments including introduction of new equipment, systems, and layout changes; 2) implementation of new equipment and process re-sequencing for a delivery catheter system component; 3) dimensional modifications to a measurement tool used for in-process inspection of the delivery catheter; and 4) addition of a new tissue supplier.