HeartWare HVAD System
FDA premarket approval P100047/S215 · decided 2024-04-29
Approval details
- PMA number
- P100047
- Supplement
- S215
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2024-02-14
- Decision date
- 2024-04-29
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for updates to the patient manual and instructions for use to add information regarding indicator lights on the controller, elevating text to warnings related to electrical alarms, and including instructions related to restarting the pump using an AC power adapter which were previously provided in a Field Action letter
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