PMA P180036S001
- Device
- Optimizer Smart System (IPG)
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S001
- Product code
- QFV
- Decision date
- 2019-05-21
- Classification
- Implantable Pulse Generator
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for updated labeling reflecting the increase in projected battery longevity of the OPTIMIZER SMART IPG.
Current openFDA PMA Record#
- Device
- Optimizer Smart System (IPG)
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S001
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2019-05-21
- Decision code
- APPR
- Date received
- 2019-04-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updated labeling reflecting the increase in projected battery longevity of the OPTIMIZER SMART IPG.