PMA P180036S039

Device: OPTIMIZER Smart System
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S039
Product code: QFV
Decision date: 2025-04-08
Classification: Cardiovascular
Generic name: Implantable pulse generator
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180036

Current openFDA PMA Record#

Device: OPTIMIZER Smart System
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S039
Product code: QFV
Generic name: Implantable pulse generator
Decision date: 2025-04-08
Decision code: APPR
Date received: 2025-03-10
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P180036