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 | VNS THERAPY DEMIPULSE & DEMIPULSE DUO GENERATORS |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S098 |
Date Received | 02/04/2008 |
Decision Date | 04/03/2008 |
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 TWO CHANGES TO HE PULSE GENERATOR SOFTWARE TO ELIMINATE A RARE TIMING CONDITION THAT MAY CAUSE THE SOFTWARE WATCHDOG TO, AT THE END OF A MAGNET-INITIATED BURST, REPORT AN ERROR EVEN THOUGH NO SUCH ERROR OCCURRED. |
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