PMA P100026S039
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S039
- Product code
- PFN
- Decision date
- 2015-12-09
- Classification
- Implanted Brain Stimulator For Epilepsy
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- ADDITION OF A CLEANING STEP AND CLEANING SOLUTION TO THE MANUFACTURING PROCESS THAT PRODUCES THE LEAD RING MARKER.
Current openFDA PMA Record#
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S039
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2015-12-09
- Decision code
- OK30
- Date received
- 2015-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A CLEANING STEP AND CLEANING SOLUTION TO THE MANUFACTURING PROCESS THAT PRODUCES THE LEAD RING MARKER.