FDA.reportPublic FDA data

PMA P100026S083

Device
NeuroPace RNS System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S083
Product code
PFN
Decision date
2020-07-14
Generic name
Implanted brain stimulator for epilepsy
Approval order statement
Use of an alternate sub-tier supplier to cut the polyester mesh, which is subsequently fully encapsulated within the NeuroPace Cortical Strip Leads during manufacturing.

Current openFDA PMA Record#

Device
NeuroPace RNS System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S083
Product code
PFN
Generic name
Implanted brain stimulator for epilepsy
Decision date
2020-07-14
Decision code
OK30
Date received
2020-07-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Use of an alternate sub-tier supplier to cut the polyester mesh, which is subsequently fully encapsulated within the NeuroPace Cortical Strip Leads during manufacturing.