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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 | S005 |
Date Received | 07/15/2011 |
Decision Date | 08/12/2011 |
Product Code | |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |