Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
DeviceNeuRX Diaphragm Pacing System (DPS)
Generic Namediaphragmatic/phrenic nerve laparoscopically-implanted stimulator
ApplicantSynapse Biomedical, Inc.
300 Artino Street
Oberlin, OH 44074
PMA NumberP200018
Date Received03/12/2020
Decision Date03/31/2023
Product Code OIR 
Docket Number 23M-1306
Notice Date 04/06/2023
Advisory Committee Anesthesiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the NeuRx DPS® is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
-
-