PMA P180036
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S015
- Product code
- QFV
- Decision date
- 2026-09-24
- Generic name
- Implantable pulse generator
- Approval order statement
- approval for implementing a new fuse with improved suitability
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S044
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2026-09-24
- Decision code
- APPR
- Date received
- 2026-06-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for implementing a new fuse with improved suitability