COREVALVE (TM) EVOLUT(TM) R SYSTEM

FDA premarket approval P130021/S014 · decided 2015-06-22

Approval details

PMA number

P130021

Supplement

S014

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

COREVALVE (TM) EVOLUT(TM) R SYSTEM

Generic name

Aortic valve, prosthesis, percutaneously delivered

Applicant

Medtronic, Inc.

Date received

2015-04-23

Decision date

2015-06-22

Days to decision

60 days

Decision code

APPR

Product code

NPT

Advisory committee

Cardiovascular

Expedited review

No

Location

Miinneapolis, MN

Statement

APPROVAL FOR A DESIGN ITERATION OF THE 23, 26, AND 29 MM MEDTRONIC COREVALVE SYSTEM. THE NEW COMPONENTS INCLUDE COREVALVE EVOLUT R TRANSCATHETER AORTIC VALVES, MODELS EVOLUTR-23-US, EVOLUTR-26-US, AND EVOLUTR-29-US, ENVEO R DELIVERY CATHETER SYSTEM, MODEL ENVEOR-US, AND ENVEO R LOADING SYSTEMS, MODELS LS-ENVEOR-23US AND LS-ENVEOR-2629US. THESE COMPONENTS WILL BE MARKETED UNDER THE TRADE NAME COREVALVE EVOLUT R SYSTEM.

510(k) clearances by this applicant