Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.

• 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 st.; oberline, OH 44074
• HDE Number: H070003
• Supplement Number: S005
• Date Received: 07/15/2011
• Decision Date: 08/12/2011
• Product Code: OIR [ Registered Establishments with OIR ]
• Advisory Committee: Anesthesiology
• Supplement Type: 30-day notice
• Supplement Reason: process change - manufacturer/sterilizer/packager/supplier
• Expedited Review Granted?: No
• Combination Product: No