PMA P100047S090
- Device
- HeartWare™ HVAD™ System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S090
- Product code
- DSQ
- Decision date
- 2017-09-27
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for the HeartWare HVAD System. This device is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf10/P100047S090B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- HeartWare™ HVAD™ System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S090
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-09-27
- Decision code
- APPR
- Date received
- 2017-01-31
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the HeartWare HVAD System. This device is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.