PMA P100047S223
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S223
- Product code
- DSQ
- Decision date
- 2026-04-10
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a new HVAD battery charger, a new packaging configuration for the HVAD power cords, and labeling updates.
Current openFDA PMA Record#
- Device
- HEARTWARE VENTRICULAR ASSIST SYSTEM
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S223
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-04-10
- Decision code
- APPR
- Date received
- 2025-03-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a new HVAD battery charger, a new packaging configuration for the HVAD power cords, and labeling updates.