PMA P180036S010
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S010
- Product code
- QFV
- Decision date
- 2021-10-15
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S010
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2021-10-15
- Decision code
- APPR
- Date received
- 2021-09-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.