PMA P100026S069
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- Product code
- PFN
- Decision date
- 2020-02-20
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval for the MRI Conditional labeling for the RNS system products.
Current openFDA PMA Record#
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S069
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2020-02-20
- Decision code
- APPR
- Date received
- 2019-05-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the MRI Conditional labeling for the RNS system products.