OPTIMIZER Smart System
FDA premarket approval P180036/S002 · decided 2019-08-13
Approval details
- PMA number
- P180036
- Supplement
- S002
- Supplement type
- Real-Time Process
- 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
- 2019-06-21
- Decision date
- 2019-08-13
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- QFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Marlton, NJ
- Statement
- Approval for changes to the circuit components of the OPTIMIZER Smart IPG to improve manufacturability, robustness, and reliability.
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