OPTIMIZER® Smart System
FDA premarket approval P180036/S026 · decided 2024-01-03
Approval details
- PMA number
- P180036
- Supplement
- S026
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPTIMIZER® Smart System
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2023-12-22
- Decision date
- 2024-01-03
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- to add a refurbishment process for the Mini Charger by replacing the battery pack
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