NEUROPACE RNS SYSTEM
FDA premarket approval P100026 · decided 2013-11-14
Approval details
- PMA number
- P100026
- Trade name
- NEUROPACE RNS SYSTEM
- Generic name
- Implanted brain stimulator for epilepsy
- Applicant
- NeuroPace, Inc.
- Date received
- 2010-07-02
- Decision date
- 2013-11-14
- Days to decision
- 1231 days
- Decision code
- APPR
- Product code
- PFN
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Mountain View, CA
- Statement
- APPROVAL FOR THE RNS SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS: " ... AS AN ADJUNCTIVE THERAPY IN REDUCING THE FREQUENCY OF SEIZURES IN INDIVIDUALS 18 YEARS OF AGE OR OLDER WITH PARTIAL ONSET SEIZURES WHO HAVE UNDERGONE DIAGNOSTIC TESTING THAT LOCALIZEDNO MORE THAN 2 EPILEPTOGENIC FOCI, ARE REFRACTORY TO TWO OR MORE ANTIEPILEPTIC MEDICATIONS, AND CURRENTLY HAVE FREQUENT AND DISABLING SEIZURES (MOTOR PARTIAL SEIZURES, COMPLEX PARTIAL SEIZURESAND/ OR SECONDARILY GENERALIZED SEIZURES). THE RNS SY
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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 |