PMA P100026S063

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S063
Product code: PFN
Decision date: 2019-09-19
Classification: Implanted Brain Stimulator For Epilepsy
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: Approval for the current NeuroPace supplier of the Tunneling Tool Straw (Straw), Teleflex Medical OEM (located at 50 Plantation Drive, Jaffrey NH 03452), to source raw polytetrafluoroethylene (PTFE) resin used in the Straw manufacture from an alternate supplier.

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S063
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2019-09-19
Decision code: APPR
Date received: 2019-02-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the current NeuroPace supplier of the Tunneling Tool Straw (Straw), Teleflex Medical OEM (located at 50 Plantation Drive, Jaffrey NH 03452), to source raw polytetrafluoroethylene (PTFE) resin used in the Straw manufacture from an alternate supplier.