PMA P180036S024
- Device
- OPTIhome Remote Patient Monitoring System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S024
- Product code
- QFV
- Decision date
- 2023-12-01
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- approval for changes to the OPTIhome Remote Patient Monitoring System software for the OPTIMIZER Smart Mini System
Current openFDA PMA Record#
- Device
- OPTIhome Remote Patient Monitoring System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S024
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2023-12-01
- Decision code
- APPR
- Date received
- 2023-09-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for changes to the OPTIhome Remote Patient Monitoring System software for the OPTIMIZER Smart Mini System