PMA P100026S040
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S040
- Product code
- PFN
- Decision date
- 2016-03-15
- Classification
- Implanted Brain Stimulator For Epilepsy
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval of an alternate supplier to manufacture a lead coil assembly, and resultant minor specification tolerance and testing changes.
Current openFDA PMA Record#
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S040
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2016-03-15
- Decision code
- APPR
- Date received
- 2015-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of an alternate supplier to manufacture a lead coil assembly, and resultant minor specification tolerance and testing changes.