PMA P100026S043
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S043
- Product code
- PFN
- Decision date
- 2016-07-28
- Classification
- Implanted Brain Stimulator For Epilepsy
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval for changes on the design of the Wand, which is used for communication between the Neurostimulator and the Remote Monitor, and the Neurostimulator and the Programmer.
Current openFDA PMA Record#
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S043
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2016-07-28
- Decision code
- APPR
- Date received
- 2016-04-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes on the design of the Wand, which is used for communication between the Neurostimulator and the Remote Monitor, and the Neurostimulator and the Programmer.