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Trade Name | NEURX DIAPHRAGM PACING SYSTEM (DPS) |
Classification Name | diaphragmatic/phrenic nerve laparoscopically-implanted stimulator |
Generic Name | diaphragmatic/phrenic nerve laparoscopically-implanted stimulator |
Applicant |
SYNAPSE BIOMEDICAL |
300 artino street |
oberlin, OH 44074 |
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HDE Number | H070003 |
Supplement Number | S009 |
Date Received | 01/10/2013 |
Decision Date | 04/02/2013 |
Product Code | |
Advisory Committee |
Anesthesiology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a design change involving the electrode delivery instrument to weld the electrode insertion needle to the pivot wheel, and is indicated for the treatment of spinal cord injury. |