PMA P180036S003
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S003
- Product code
- QFV
- Decision date
- 2019-10-23
- Classification
- Implantable Pulse Generator
- Generic name
- Implantable pulse generator
- Approval order statement
- Approval for the 2-lead OPTIMIZER Smart Cardiac Contractility Modulation System.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S003
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2019-10-23
- Decision code
- APPR
- Date received
- 2019-08-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the 2-lead OPTIMIZER Smart Cardiac Contractility Modulation System.