PMA P100026S084
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S084
- Product code
- PFN
- Decision date
- 2020-09-28
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval to update the protocols and associated data collection and informed consent forms for PAS 2 and PAS 3 due to the current public health emergency.
Current openFDA PMA Record#
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S084
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2020-09-28
- Decision code
- APPR
- Date received
- 2020-08-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval to update the protocols and associated data collection and informed consent forms for PAS 2 and PAS 3 due to the current public health emergency.