HeartWare Left Ventricular Assist System
FDA premarket approval P100047/S082 · decided 2017-04-06
Approval details
- PMA number
- P100047
- Supplement
- S082
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartWare Left Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2016-08-19
- Decision date
- 2017-04-06
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for electrical, hardware, and software modifications to the controller, monitor, and AC/DC adapters.
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