NeuroPace RNS System
FDA premarket approval P100026/S063 · decided 2019-09-19
Approval details
- PMA number
- P100026
- Supplement
- S063
- Supplement type
- 135 Review Track For 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
- 2019-02-06
- Decision date
- 2019-09-19
- Days to decision
- 225 days
- Decision code
- APPR
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- 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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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 |