PMA P180036S041

Device
GUARDIO/VESTA Charger
Applicant
Impulse Dynamics (Usa), Inc.
PMA number
P180036
Supplement
S041
Product code
QFV
Decision date
2026-04-10
Classification
Cardiovascular
Generic name
Implantable pulse generator
Approval order statement
Approval for design changes to the GUARDIO/VESTA Charger power supply connector.

Current openFDA PMA Record#

Device
GUARDIO/VESTA Charger
Applicant
Impulse Dynamics (Usa), Inc.
PMA number
P180036
Supplement
S041
Product code
QFV
Generic name
Implantable pulse generator
Decision date
2026-04-10
Decision code
APPR
Date received
2026-01-12
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for design changes to the GUARDIO/VESTA Charger power supply connector.