Implanted Brain Stimulator For Epilepsy
Basic Information
- Device Name
- Implanted Brain Stimulator For Epilepsy
- Trade Name
- NEUROPACE RNS SYSTEM
- PMA Number
- P100026
- Device Class
- FDA Class 3
- Product Code
- PFN
- Generic Name
- Implanted brain stimulator for epilepsy
- Medical Specialty
- Unknown
- Advisory Committee
- Neurology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 14, 2013
- Date Received
- July 2, 2010
- Expedited Review
- N
- Docket Number
- 12M-1488
Advisory Committee 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 SYSTEM HAS DEMONSTRATED SAFETY AND EFFECTIVENESS IN PATIENTS WHO AVERAGE 3 OR MORE DISABLING SEIZURES PER MONTH OVER THE THREE MOST RECENT MONTHS (WITH NO MONTH WITH FEWER THAN TWO SEIZURES), AND HAS NOT BEEN EVALUATED IN PATIENTS WITH LESS FREQUENT SEIZURES."
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PFN | Implanted Brain Stimulator For Epilepsy | FDA class 3 | Unknown |