HeartWare HVAD System
FDA premarket approval P100047/S101 · decided 2017-12-15
Approval details
- PMA number
- P100047
- Supplement
- S101
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HeartWare HVAD System
- Generic name
- Ventricular (assist) bypass
- Applicant
- Medtronic
- Date received
- 2017-06-20
- Decision date
- 2017-12-15
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- DSQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of cleaning specifications and ongoing controls and monitoring requirements to verify compliance to the new cleanliness specifications.
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| CD Horizon™ Spinal System (K221244) | Medtronic | 2022-05-25 |