OPTIMIZER® Smart Mini System
FDA premarket approval P180036/S022 · decided 2023-09-18
Approval details
- PMA number
- P180036
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIMIZER® Smart Mini System
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2023-05-10
- Decision date
- 2023-09-18
- Days to decision
- 131 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- Approval for changes to the printed circuit board (PCB), including the location of the thermistor component.
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