HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
FDA premarket approval P100047/S075 · decided 2016-06-23
Approval details
- PMA number
- P100047
- Supplement
- S075
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEARTWARE LEFT VENTRICULAR ASSIST SYSTEM
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2016-05-25
- Decision date
- 2016-06-23
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the manufacturing process updates for the HeartWare Left Ventricular Assist Device Controller.
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