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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNeuroPace RNS System
Generic NameImplanted brain stimulator for epilepsy
ApplicantNEUROPACE INC
455 N. BERNARDO AVE
MOUNTAIN VIEW, CA 94043
PMA NumberP100026
Supplement NumberS063
Date Received02/06/2019
Decision Date09/19/2019
Product Code PFN 
Advisory Committee Neurology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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.
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