PMA P180036S002
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S002
- Product code
- QFV
- Decision date
- 2019-08-13
- Classification
- Implantable Pulse Generator
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for changes to the circuit components of the OPTIMIZER Smart IPG to improve manufacturability, robustness, and reliability.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S002
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2019-08-13
- Decision code
- APPR
- Date received
- 2019-06-21
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for changes to the circuit components of the OPTIMIZER Smart IPG to improve manufacturability, robustness, and reliability.