PMA P160039S006

Device: remede System
Applicant: Respicardia
PMA number: P160039
Supplement: S006
Product code: PSR
Decision date: 2021-07-28
Generic name: Implanted phrenic nerve stimulator for central sleep apnea
Approval order statement: Approval for reducing the IPG size, increasing the IPG battery longevity, reducing the number of set screw connections between the lead terminal and IPG header, and improving features within the Remede Programer software application and the remede Reports application.

Current openFDA PMA Record#

Device: remede System
Applicant: Respicardia
PMA number: P160039
Supplement: S006
Product code: PSR
Generic name: Implanted phrenic nerve stimulator for central sleep apnea
Decision date: 2021-07-28
Decision code: APPR
Date received: 2021-01-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for reducing the IPG size, increasing the IPG battery longevity, reducing the number of set screw connections between the lead terminal and IPG header, and improving features within the Remede Programer software application and the remede Reports application.