FDA.reportPublic FDA data

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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00763000923655HeartWare™ Battery - BATTERY 1650MCS+1(800)633-8766Corporate.UDI@medtronic.com
00763000989514HVAD™ Controller - CONTROLLER MCS1421CN WW+1(800)633-8766Corporate.UDI@medtronic.com

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#

GUDID#

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