PMA P100047S235

Device: HeartWare HVAD System
Applicant: Medtronic
PMA number: P100047
Supplement: S235
Product code: DSQ
Decision date: 2026-04-07
Classification: Cardiovascular
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for changes to the HVAD Battery Pack including: 1) adjusting the State of Charge (SOC) to no greater than 30%, 2) enabling the Sleep Mode feature before packaging and shipping, 3) adding a new ICAO Packing Instruction (PI) 966 for UN3481, 4) adding a ‘Sleep Mode Battery Charger/Discharger’ as a new manufacturing process equipment, and 5) discontinuing the HVAD Batteries recharge process.

Current openFDA PMA Record#

Device: HeartWare HVAD System
Applicant: Medtronic
PMA number: P100047
Supplement: S235
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2026-04-07
Decision code: APPR
Date received: 2025-11-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the HVAD Battery Pack including: 1) adjusting the State of Charge (SOC) to no greater than 30%, 2) enabling the Sleep Mode feature before packaging and shipping, 3) adding a new ICAO Packing Instruction (PI) 966 for UN3481, 4) adding a ‘Sleep Mode Battery Charger/Discharger’ as a new manufacturing process equipment, and 5) discontinuing the HVAD Batteries recharge process.