HeartWare Ventricular Assist System
FDA premarket approval P100047/S133 · decided 2019-02-21
Approval details
- PMA number
- P100047
- Supplement
- S133
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- HeartWare Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2018-12-17
- Decision date
- 2019-02-21
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval of the protocol changes for the post-approval study (PAS) protocol.
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