PMA P180036S006
- Device
- OPTIMIZER Smart System (2-Lead configuration)
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S006
- Product code
- QFV
- Decision date
- 2020-12-30
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for MR Conditional labeling for the OPTIMIZER Smart when combined with certain market approved pacing leads.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart System (2-Lead configuration)
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S006
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2020-12-30
- Decision code
- APPR
- Date received
- 2020-06-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for MR Conditional labeling for the OPTIMIZER Smart when combined with certain market approved pacing leads.