Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | NEUROCYBERNETIC PROTHESIS SYSTEM |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S004 |
Date Received | 09/18/1997 |
Decision Date | 01/29/1998 |
Product Code |
LYJ |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for NCP(R) Model 100C Pulse Generator with modifications to the microcontroller and battery. The device, as modified, will be marketed under the trade name NCP(R) Model 100C Pulse Generator ans is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with pertial onset seizures, which are refractory to anti-epileptic medications. |
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