PMA P100047S236
- Device
- HeartWare® HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S236
- Product code
- DSQ
- Decision date
- 2026-02-03
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- changes related to upgrades of the HVAD Battery Packtesters
Current openFDA PMA Record#
- Device
- HeartWare® HVAD System
- Applicant
- Medtronic
- PMA number
- P100047
- Supplement
- S236
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-02-03
- Decision code
- OK30
- Date received
- 2026-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes related to upgrades of the HVAD Battery Packtesters