Author: [none given]
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,