Evolut FX device

FDA premarket approval P130021/S103 · decided 2021-09-22

Approval details

PMA number

P130021

Supplement

S103

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

Evolut FX device

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Medtronic, Inc.

Date received

2021-09-13

Decision date

2021-09-22

Days to decision

9 days

Decision code

OK30

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

Miinneapolis, MN

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.

510(k) clearances by this applicant