HeartWare HVAD System
FDA premarket approval P100047/S200 · decided 2022-09-08
Approval details
- PMA number
- P100047
- Supplement
- S200
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2022-05-26
- Decision date
- 2022-09-08
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for various updates to the Instructions for Use to add the final clinical results of the post-approval studies entitled Newly Enrolled (HW-PAS-01) Training Program (HeartWare-PAS-02), and Cont F/u of HW004-A ENDURANCE.
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