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.
 
DeviceAltius® Direct Electrical Nerve Stimulation System
Generic Namestimulator, nerve terminus, totally implanted for chronic intractable post-amputation pain of the lower limb
ApplicantNeuros Medical, Inc.
26800 Aliso Viejo Pkwy.
Suite 250
Aliso Viejo, CA 92656
PMA NumberP230020
Supplement NumberS005
Date Received07/07/2025
Decision Date12/03/2025
Product Code SAZ 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a manufacturing site located at Neuros Medical, Inc., 1212 Red Fox Road, Arden Hills, Minnesota, 55112. The main manufacturing operations performed at this facility include, but are not limited to, the receipt of sterile and non-sterile finished packaged devices ready for distribution from two contract manufacturing organization facilities, evaluation of returned devices, calibration and maintenance of inspection equipment, and serve as the specification developer and design control center.
-
-