PMA P180036S018
- Device
- VESTA/GUARDIO Charger
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S018
- Product code
- QFV
- Decision date
- 2023-07-17
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for modifications of the VESTA/GUARDIO Charger firmware.
Current openFDA PMA Record#
- Device
- VESTA/GUARDIO Charger
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S018
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2023-07-17
- Decision code
- APPR
- Date received
- 2023-04-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications of the VESTA/GUARDIO Charger firmware.