HeartWare Left Ventricular Assist Device System
FDA premarket approval P100047/S103 · decided 2017-08-17
Approval details
- PMA number
- P100047
- Supplement
- S103
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartWare Left Ventricular Assist Device System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2017-07-20
- Decision date
- 2017-08-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Addition of tolerances to a specification and a revised inspection method for seal strength at the supplier of the HeartWare Ventricular Assist Device Outflow Graft.
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