HeartWare, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30070423193007042319HeartWare, Inc.1N2026-01-0114400 NW 60th Ave Miami Lakes FL US 33014

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1986162026924788P100047HEARTWARE VENTRICULAR ASSIST SYSTEMDSQ2012-11-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DSQ12012-11-20

PMN#