PMA P100047S238
- Device
- Heart Ware™ Ventricular Assist System (HVAD)
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S238
- Product code
- DSQ
- Decision date
- 2026-05-14
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- addition of an alternate component for an integrated circuit on the HVAD controller
Current openFDA PMA Record#
- Device
- Heart Ware™ Ventricular Assist System (HVAD)
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S238
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-05-14
- Decision code
- OK30
- Date received
- 2026-04-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternate component for an integrated circuit on the HVAD controller