PMA P180036S020

Device: OPTIMIZER Smart Mini Implantable Pulse Generation (IPG)
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S020
Product code: QFV
Decision date: 2023-10-23
Classification: Cardiovascular
Generic name: Implantable pulse generator
Approval order statement: Approval for expanded MR Conditional labeling for the OPTIMIZER Smart Mini when combined with certain market approved pacing leads.

Current openFDA PMA Record#

Device: OPTIMIZER Smart Mini Implantable Pulse Generation (IPG)
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S020
Product code: QFV
Generic name: Implantable pulse generator
Decision date: 2023-10-23
Decision code: APPR
Date received: 2023-05-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for expanded MR Conditional labeling for the OPTIMIZER Smart Mini when combined with certain market approved pacing leads.