HeartWare HVAD System
FDA premarket approval P100047/S090 · decided 2017-09-27
Approval details
- PMA number
- P100047
- Supplement
- S090
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2017-01-31
- Decision date
- 2017-09-27
- Days to decision
- 239 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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.
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