PMA P180036S013

Device: OPTIMIZER SMART MINI, INTELIO Programmer, OPTIhome Remote Patient Monitoring System, Universal GUARDIO
Applicant: Impulse Dynamics (Usa), Inc.
Product code: QFV
Decision date: 2022-12-02
Generic name: Implantable pulse generator
Approval order statement: Approval for changes made to the GUARDIO Charger as well as other related changes to device components to accommodate its use with the OPTIhome system.

Current openFDA PMA Record#

Device: OPTIMIZER SMART MINI, INTELIO Programmer, OPTIhome Remote Patient Monitoring System, Universal GUARDIO
Applicant: Impulse Dynamics (Usa), Inc.
PMA number: P180036
Supplement: S013
Product code: QFV
Generic name: Implantable pulse generator
Decision date: 2022-12-02
Decision code: APPR
Date received: 2022-04-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes made to the GUARDIO Charger as well as other related changes to device components to accommodate its use with the OPTIhome system.