PMA P100026S076
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S076
- Product code
- PFN
- Decision date
- 2019-11-05
- Classification
- Implanted Brain Stimulator For Epilepsy
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Manufacturing process changes to printed circuit assembly, interlay, and top can barrier tape for the RNS Neurostimulator, Model 320.
Current openFDA PMA Record#
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S076
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2019-11-05
- Decision code
- OK30
- Date received
- 2019-10-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process changes to printed circuit assembly, interlay, and top can barrier tape for the RNS Neurostimulator, Model 320.