PMA P100047S240
- Device
- HeartWare™ HVAD™ System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S240
- Product code
- DSQ
- Decision date
- 2026-08-05
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for end-user sterilization of the Sewing Ring Wrench
Current openFDA PMA Record#
- Device
- HeartWare™ HVAD™ System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S240
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-08-05
- Decision code
- APPR
- Date received
- 2026-05-08
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for end-user sterilization of the Sewing Ring Wrench