HeartWare HVAD System
FDA premarket approval P100047/S132 · decided 2020-07-09
Approval details
- PMA number
- P100047
- Supplement
- S132
- 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
- 2018-11-02
- Decision date
- 2020-07-09
- Days to decision
- 615 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for modifications to the design of the outflow graft and strain relief, as well as modifications to the associated tools, packaging, and labeling. The modified design includes an Outflow Graft with an added Titanium Ring, a Strain Relief Clamp with a captured screw, and a Strain Relief Wrench to replace the Hex Driver
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