HeartWare HVAD System
FDA premarket approval P100047/S138 · decided 2019-07-09
Approval details
- PMA number
- P100047
- Supplement
- S138
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2019-04-11
- Decision date
- 2019-07-09
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of lubrication to the production process for the power connector pins of the AC and DC adapters and batteries of the HVAD System.
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