PMA P180036S012
- Device
- OPTIMIZER Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- Product code
- QFV
- Decision date
- 2022-11-14
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for the OPTIhome Remote Patient Monitoring System and Patient App for use as accessories to the OPTIMIZER Smart Mini System.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S012
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2022-11-14
- Decision code
- APPR
- Date received
- 2021-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the OPTIhome Remote Patient Monitoring System and Patient App for use as accessories to the OPTIMIZER Smart Mini System.