NeuroPace RNS System
FDA premarket approval P100026/S056 · decided 2018-08-01
Approval details
- PMA number
- P100026
- Supplement
- S056
- 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
- 2018-07-03
- Decision date
- 2018-08-01
- Days to decision
- 29 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) power-up software to improve yield of the components used to manufacture the RNS® Neurostimulator (model RNS-320) during the custom packaged integrated circuitry (Cassandra) and printed circuit assembly (PCA) testing. Additionally, the Dog Tag test limits for the integrated circuit are being modified in the PXI Vader ATE, Telemetry Only System (TOS) ATE and the PXI Vader Temperature ATE databases to allow flexibility to also test future integra
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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 |