|
Trade Name | NEURX RA/4 DEVICE |
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 |
|
HDE Number | H070003 |
Supplement Number | S001 |
Date Received | 10/20/2008 |
Decision Date | 02/03/2009 |
Product Code | |
Advisory Committee |
Anesthesiology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |