PMA P180036S027
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S027
- Product code
- QFV
- Decision date
- 2024-04-12
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator
- Approval order statement
- approval of the revised protocol (version 8) for the post-approval study (PAS) referenced above.
Current openFDA PMA Record#
- Device
- OPTIMIZER Smart System
- Applicant
- Impulse Dynamics (Usa), Inc.
- PMA number
- P180036
- Supplement
- S027
- Product code
- QFV
- Generic name
- Implantable pulse generator
- Decision date
- 2024-04-12
- Decision code
- APPR
- Date received
- 2024-03-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval of the revised protocol (version 8) for the post-approval study (PAS) referenced above.