PMA P100047S110
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S110
- Product code
- DSQ
- Decision date
- 2018-06-22
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a modification to the HeartWare HVAD System’s driveline outer sheath material.
Current openFDA PMA Record#
- Device
- HeartWare HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S110
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2018-06-22
- Decision code
- APPR
- Date received
- 2017-09-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to the HeartWare HVAD System’s driveline outer sheath material.