NeuroPace RNS System
FDA premarket approval P100026/S070 · decided 2019-08-01
Approval details
- PMA number
- P100026
- Supplement
- S070
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- NeuroPace RNS System
- Generic name
- Implanted brain stimulator for epilepsy
- Applicant
- NeuroPace, Inc.
- Date received
- 2019-06-03
- Decision date
- 2019-08-01
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- Approval for the following protocol changes and associated changes to data collection and informed consent forms:1) Increase the upper limit on the number of subjects that can be implanted per study site;2) Simplify the text to remove references to activities that are not study-specific (i.e. are standard in the management of the RNS System);3) Revise inclusion/exclusion criteria to only include study-specific criteria;4) Add the option of phone appointments for specific follow-up time points; a
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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 |