PMA P100026S045
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S045
- Product code
- PFN
- Decision date
- 2016-12-06
- Classification
- Implanted Brain Stimulator For Epilepsy
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Transfer manufacturing of the Ball Grid Array to a new component manufacturer.
Current openFDA PMA Record#
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S045
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2016-12-06
- Decision code
- OK30
- Date received
- 2016-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Transfer manufacturing of the Ball Grid Array to a new component manufacturer.