HeartWare HVAD System
FDA premarket approval P100047/S169 · decided 2020-12-21
Approval details
- PMA number
- P100047
- Supplement
- S169
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2020-07-01
- Decision date
- 2020-12-21
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a change in material (from nylon to PEEK) of 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 labeling and manufacturing changes.
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