PMA P180036S031

Device: GUARDIO/VESTA Charger firmware
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S031
Product code: QFV
Decision date: 2024-08-30
Classification: Cardiovascular
Generic name: Implantable pulse generator
Approval order statement: approval for changes to the GUARDIO and VESTA charger firmware, including updates and improvements to routines used when communicating with the cellular network, and to include a new information screen

Current openFDA PMA Record#

Device: GUARDIO/VESTA Charger firmware
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S031
Product code: QFV
Generic name: Implantable pulse generator
Decision date: 2024-08-30
Decision code: APPR
Date received: 2024-06-05
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for changes to the GUARDIO and VESTA charger firmware, including updates and improvements to routines used when communicating with the cellular network, and to include a new information screen