OPTIMIZER Smart Mini IPG
FDA premarket approval P180036/S025 · decided 2024-02-09
Approval details
- PMA number
- P180036
- Supplement
- S025
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPTIMIZER Smart Mini IPG
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2023-12-04
- Decision date
- 2024-02-09
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- approval for implantable pulse generator firmware version 1.11 to update the charging algorithm and bug fixes.
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