PMA P100047S241
- Device
- HeartWare® HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S241
- Product code
- DSQ
- Decision date
- 2026-09-23
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for labeling updates to reflect previously approved design changes, strengthen existing cybersecurity warnings, and make editorial changes.
Current openFDA PMA Record#
- Device
- HeartWare® HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S241
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-09-23
- Decision code
- APPR
- Date received
- 2026-08-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates to reflect previously approved design changes, strengthen existing cybersecurity warnings, and make editorial changes.