PMA P180036S004
- Device
- OPTIMIZER Smart IPG
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S004
- Product code
- QFV
- Decision date
- 2020-02-28
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for shelf life extension to 2 years.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart IPG
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S004
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2020-02-28
- Decision code
- APPR
- Date received
- 2020-01-09
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for shelf life extension to 2 years.