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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 | H100006 |
Supplement Number | S003 |
Date Received | 09/14/2012 |
Decision Date | 11/06/2012 |
Product Code | |
Advisory Committee |
Anesthesiology |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the post-approval study protocol. |