OPTIMIZER SMART Mini IPG
FDA premarket approval P180036/S034 · decided 2025-11-19
Approval details
- PMA number
- P180036
- Supplement
- S034
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPTIMIZER SMART Mini IPG
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2024-08-15
- Decision date
- 2025-11-19
- Days to decision
- 461 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- a process change for epoxy headers of OPTIMIZER implantable pulse generators
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