NeuroPace RNS System
FDA premarket approval P100026/S068 · decided 2019-05-24
Approval details
- PMA number
- P100026
- Supplement
- S068
- 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
- 2019-05-21
- Decision date
- 2019-05-24
- Days to decision
- 3 days
- Decision code
- OK30
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Addition of a new wafer sort test to the manufacturing flow of the RNS® Neurostimulator (model RNS-320). This testing service will be performed at a new supplier, NeuroPaces approved supplier Integra Technologies (located at 1635 McCarthy Blvd, Milpitas, CA 95035).
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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 |