|
Device | HeartWare Ventricular Assist System (HVAD) |
Generic Name | Ventricular (assist) bypass |
Applicant | Medtronic 8200 Coral SeaSt. N.E. Mounds View, MN 55112 |
PMA Number | P100047 |
Supplement Number | S135 |
Date Received | 02/19/2019 |
Decision Date | 03/13/2019 |
Product Code |
DSQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of two 100% in process and incoming inspections at a tier two supplier of the HVAD Battery Charger PCB. |