Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery Syste

FDA premarket approval P190023/S013 · decided 2023-09-15

Approval details

PMA number

P190023

Supplement

S013

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery Syste

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

ABBOTT MEDICAL

Date received

2023-03-20

Decision date

2023-09-15

Days to decision

179 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

St. Paul, MN

Statement

Approval for a design modification to the Navitor Transcatheter Heart Valve for the addition of three radiopaque markers (RO markers) to the valve annulus section (Vision technology), minor changes to etching on the Navitor Loading System (LS LG+), and approval of the 35mm Navitor Titan size extension which will also incorporate the three RO markers.

510(k) clearances by this applicant