PMA P180036S016
- Device
- OPTIMIZER Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S016
- Product code
- QFV
- Decision date
- 2023-03-21
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for design changes to the GUARDIO/VESTA charger power supply.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S016
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2023-03-21
- Decision code
- APPR
- Date received
- 2022-12-23
- 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.