NeuroPace RNS System
FDA premarket approval P100026/S073 · decided 2019-08-08
Approval details
- PMA number
- P100026
- Supplement
- S073
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NeuroPace RNS System
- Generic name
- Implanted brain stimulator for epilepsy
- Applicant
- NeuroPace, Inc.
- Date received
- 2019-08-02
- Decision date
- 2019-08-08
- Days to decision
- 6 days
- Decision code
- OK30
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Modify the PXI Vader automated test equipment (ATE) software to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320) during the custom packaged integrated circuit (Cassandra) and printed circuit assembly (PCA) testing. In addition, this submission includes an update to PXI Vader ATE software for final electrical test to support future product changes currently under development.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| NEUROPACE BURR HOLE COVER (K141368) | NeuroPace, Inc. | 2014-07-11 |
| NEUROPACE BURR HOLE COVER MODEL 8110 (K123163) | NeuroPace, Inc. | 2013-01-18 |