PMA P180036S032
- Device
- GUARDIO/VESTA charger
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S032
- Product code
- QFV
- Decision date
- 2024-11-06
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- modifications to the design of the Guardio/Vesta charger cable, shielding and ferrites
Current openFDA PMA Record#
- Device
- GUARDIO/VESTA charger
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S032
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2024-11-06
- Decision code
- APPR
- Date received
- 2024-08-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- modifications to the design of the Guardio/Vesta charger cable, shielding and ferrites