HeartWare Ventricular Assist System
FDA premarket approval P100047/S159 · decided 2020-11-23
Approval details
- PMA number
- P100047
- Supplement
- S159
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartWare Ventricular Assist System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2020-04-03
- Decision date
- 2020-11-23
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a retrospective approval of the change in the HVAD Outflow Graft soiling inspection criteria at supplier Vascutek/Terumo from subjective to objective.
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