PMA P100026S065
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S065
- Product code
- PFN
- Decision date
- 2019-04-09
- Classification
- Implanted Brain Stimulator For Epilepsy
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval for changes to the labeling to strengthen instructions intended to enhance the safe use of the NeuroPace® Magnet.
Current openFDA PMA Record#
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S065
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2019-04-09
- Decision code
- APPR
- Date received
- 2019-03-11
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the labeling to strengthen instructions intended to enhance the safe use of the NeuroPace® Magnet.