PMA P180036S005
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S005
- Product code
- QFV
- Decision date
- 2020-09-02
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for the removal of the contraindication Patients with permanent or long-standing persistent atrial fibrillation or flutter.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S005
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2020-09-02
- Decision code
- APPR
- Date received
- 2020-02-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the removal of the contraindication Patients with permanent or long-standing persistent atrial fibrillation or flutter.