PMA P100026S044

Device: NEUROPACE RNS SYSTEM
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S044
Product code: PFN
Decision date: 2016-11-16
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Move the location of the laser and resistance welding processes for neurostimulator and ferrule components to their new manufacturing facility in a NeuroPace’s approved sub-contractor, Cirtec Medical Systems (Cirtec), in Enfield, Connecticut.

Current openFDA PMA Record#

Device: NEUROPACE RNS SYSTEM
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S044
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2016-11-16
Decision code: OK30
Date received: 2016-10-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Move the location of the laser and resistance welding processes for neurostimulator and ferrule components to their new manufacturing facility in a NeuroPace’s approved sub-contractor, Cirtec Medical Systems (Cirtec), in Enfield, Connecticut.