HeartWare HVAD System
FDA premarket approval P100047/S189 · decided 2021-10-15
Approval details
- PMA number
- P100047
- Supplement
- S189
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2021-07-19
- Decision date
- 2021-10-15
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for dimensional changes to the internal core in the plug used in the battery, AC adapter, DC adapter, training plugs, monitor data cable, and red alarm adapter, and associated manufacturing changes.
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