NEUROPACE RNS SYSTEM
FDA premarket approval P100026/S042 · decided 2016-03-04
Approval details
- PMA number
- P100026
- Supplement
- S042
- 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
- 2016-02-03
- Decision date
- 2016-03-04
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Change to use a larger chamber for the ethylene oxide (EO) sterilization of RNS® System products at the same approved sterilization facility (Sterigenics, Salt Lake City, Utah).
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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 |