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 PROSTHESIS (NCP) SYSTEM |
Generic Name | STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY |
Applicant | LivaNova USA, Inc. 100 Cyberonics Blvd. Houston, TX 77058 |
PMA Number | P970003 |
Supplement Number | S070 |
Date Received | 07/17/2006 |
Decision Date | 09/05/2006 |
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 |
Approval Order Statement APPROVAL FOR A CHANGE FROM ADDING A STRAIN RELIEF GROMMET TO THE SERIAL DATA CABLE OF THE MODEL 201 PROGRAMMING WAND DURING FINAL ASSEMBLY TO MOLDING AN IMPROVED STRAIN RELIEF ONTO THE SERIAL DATA CABLE DURING ITS MANUFACTURE AND CHANGES TO THE TIE-DOWN USED IN THE MODEL 302 LEAD, THE MODEL 303 LEAD, AND THE MODEL 502 ACCESSORY PACK. |
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