PMA P100026S094

Device: NeuroPace® RNS® System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S094
Product code: PFN
Decision date: 2023-08-28
Classification: Neurology
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Approval for the modification of the devices Remote Monitor to allow for the use of either a Tablet or Laptop. For the tablet interface the Remote Monitor uses Wi-Fi to communicate with the PDMS SW Application. The tablet can also receive updates remotely.

Current openFDA PMA Record#

Device: NeuroPace® RNS® System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S094
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2023-08-28
Decision code: APPR
Date received: 2023-05-31
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the modification of the devices Remote Monitor to allow for the use of either a Tablet or Laptop. For the tablet interface the Remote Monitor uses Wi-Fi to communicate with the PDMS SW Application. The tablet can also receive updates remotely.