PMA P180036S008
- Device
- Optimizer Smart System and Optimizer Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S008
- Product code
- QFV
- Decision date
- 2021-10-06
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for removing the Indications For Use requirement for patients to be in normal sinus rhythm.
Current openFDA PMA Record#
- Device
- Optimizer Smart System and Optimizer Smart Mini System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S008
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2021-10-06
- Decision code
- APPR
- Date received
- 2021-06-24
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for removing the Indications For Use requirement for patients to be in normal sinus rhythm.