|
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 |
|
HDE Number | H100006 |
Date Received | 10/12/2010 |
Decision Date | 09/28/2011 |
Product Code | |
Docket Number | 11-M0707 |
Advisory Committee |
Anesthesiology |
Clinical Trials |
NCT00010374 NCT00420719
|
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the neurx dpstm diaphragm pacing system™. This device is indicated for use in amyotrophic lateral sclerosis (als) patients with a stimulatable diaphragm (both right and left portions) as demonstrated by voluntary contraction or phrenic nerve conduction studies, and who are experiencing chronic hypoventilation (ch), but not progressed to an fvc less than 45% predicted. For use only in patients 21 years of age or older. |
Approval Order | Approval Order |
Summary | Summary of Safety And Probable Benefit |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S003 S005 S007 S008 S009 S010 S011 S012
|