OPTIMIZER Smart System
FDA premarket approval P180036/S037 · decided 2025-03-18
Approval details
- PMA number
- P180036
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIMIZER Smart System
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2024-12-20
- Decision date
- 2025-03-18
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- approval for implantable pulse generator firmware version 1.16.0 to implement bug fixes and additional improvements
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