PMA P160039S005

Device: remede® System
Applicant: Respicardia
PMA number: P160039
Supplement: S005
Product code: PSR
Decision date: 2019-12-23
Generic name: Implanted phrenic nerve stimulator for central sleep apnea
Approval order statement: Approval for software changes to the Model 7001 Remede Reports Application and the addition of Respistim LQ/LQS stimulation lead models to the family of respistim L (left) leads.

Current openFDA PMA Record#

Device: remede® System
Applicant: Respicardia
PMA number: P160039
Supplement: S005
Product code: PSR
Generic name: Implanted phrenic nerve stimulator for central sleep apnea
Decision date: 2019-12-23
Decision code: APPR
Date received: 2019-08-20
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for software changes to the Model 7001 Remede Reports Application and the addition of Respistim LQ/LQS stimulation lead models to the family of respistim L (left) leads.