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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceReactiv8 Implantable Neurostimulation System
Generic NameStimulator, neuromuscular, lower back muscles, totally implanted for pain relief
ApplicantMAINSTAY MEDICAL LIMITED
CLONMEL HOUSE FORSTER WAY
SWORDS, CO DUBLIN K67F2
PMA NumberP190021
Supplement NumberS004
Date Received01/19/2023
Decision Date02/16/2023
Product Code QLK 
Advisory Committee Neurology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Qualification of a commercially-available, equivalent programmer laptop for the ReActiv8 Implantable Neurostimulation System.
-
-