Neuropace

FDA Filings

This page includes the latest FDA filings for Neuropace. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3004426659
FEI Number	3004426659
Name	NEUROPACE
Owner & Operator	NeuroPace
Contact Address	455 N. Bernardo Avenue Mountain View CA 94043 US
Official Correspondent	Cindy Heintzelman 1-650-2372729-x
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	455 N. Bernardo Avenue Mountain View, CA 94043 US
Establishment Type	Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN P100026 \| PFN NEUROPACE	RNS System	2013-12-02
PMN P100026 \| PFN NEUROPACE	NeuroPace RNS System	2013-12-02
PMN K123163 \| GXR NEUROPACE	NeuroPace Burr Hole Cover	2013-06-05

Similar & Related FDA Registered Companies

NEUROPACE INC
NEUROPACE INC455 N. Bernardo Avemountain View, CA 94043 PMA NumberP100026 Supplement NumberS091 Date Received09/26/2022 Decision Date12/29/2022 Product Code PFN Advisory Committee Neurology Supplement Typenormal 180 Day Track No User Fee Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
NEUROPACE INC455 N. Bernardo Avemountain View, CA 94043 PMA NumberP100026 Supplement NumberS090 Date Received04/29/2022 Decision Date07/28/2022 Product Code PFN Advisory Committee Neurology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No

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