HeartWare Left Ventricular Assist System
FDA premarket approval P100047/S163 · decided 2020-11-18
Approval details
- PMA number
- P100047
- Supplement
- S163
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartWare Left Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2020-05-22
- Decision date
- 2020-11-18
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for changes to the Instructions for Use and Patient Manual as a result of remediation activities.
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