OPTIMIZER Smart System
FDA premarket approval P180036/S038 · decided 2025-07-15
Approval details
- PMA number
- P180036
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPTIMIZER Smart System
- Generic name
- Implantable pulse generator
- Applicant
- Impulse Dynamics (Usa), Inc.
- Date received
- 2025-02-19
- Decision date
- 2025-07-15
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- approval for a manufacturing site located at Integer TJS, S. de R.L. de C.V., Calle 5 Norte No. 511 Ciudad Industrial, Tijuana, Baja California, MX 22444 for the manufacture of GUARDIO/VESTA charger devices
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