HeartWare HVAD System
FDA premarket approval P100047/S166 · decided 2020-09-03
Approval details
- PMA number
- P100047
- Supplement
- S166
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2020-06-05
- Decision date
- 2020-09-03
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a change to the IFU regarding the replacement of the Monitor when the Monitor Battery no longer holds a sufficient charge.
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