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Medtronic received PMA approval for Heartware Ventricular Assist System for the addition of an alternate supplier for a component of the HeartWare Ventricular Assist System Pump

Author: [none given]

2017-05-12

Approval Order Statement  Approval for the addition of an alternate supplier for a component of the HeartWare Ventricular Assist System Pump.Device HEARTWARE VENTRICULAR ASSIST SYSTEM Classification Name Ventricular (Assisst) Bypass Generic Name         Ventricular (Assisst) Bypass Applicant Medtronic 8200 Coral Seast. N.E. Mounds View, MN 55112 PMA Number P100047 Supplement Number S089 Date Received 11/21/2016 Decision Date 05/12/2017 Product Code DSQ  [ Registered Establishments With DSQ ] Advisory Committee   Cardiovascular Supplement Type  135 Review Track for 30 day notice Process Change  Manufacturer/Sterilizer/Packager/Supplier Expedited Review Granted?    No Combination Product No

PMA Database, FDA,

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