PMA P160039S009

Device: remede System IPG
Applicant: Respicardia
PMA number: P160039
Supplement: S009
Product code: PSR
Decision date: 2023-11-09
Classification: Anesthesiology
Generic name: Implanted phrenic nerve stimulator for central sleep apnea
Approval order statement: approval for introducing ease of use features to aid clinicians when during follow up visits and extending the shelf life the GEN 1.5 Model 1100/1600 IPGs packaging from 2 years to 4 years.

Current openFDA PMA Record#

Device: remede System IPG
Applicant: Respicardia
PMA number: P160039
Supplement: S009
Product code: PSR
Generic name: Implanted phrenic nerve stimulator for central sleep apnea
Decision date: 2023-11-09
Decision code: APPR
Date received: 2023-05-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for introducing ease of use features to aid clinicians when during follow up visits and extending the shelf life the GEN 1.5 Model 1100/1600 IPGs packaging from 2 years to 4 years.