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.
 
DeviceProclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor
Generic NameDorsal root ganglion stimulator for pain relief
ApplicantABBOTT MEDICAL
6901 Preston Rd.
Plano, TX 75024
PMA NumberP150004
Supplement NumberS063
Date Received06/23/2023
Decision Date12/19/2023
Product Code PMP 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for expanded 1.5T MR conditional labeling to allow full-body scanning using integrated whole-body RF coils with any receive coil for the Proclaim DRG IPG (Model 3664) when implanted with the DRG 50cm leads (models MN10450-50, MN10450-50A) and associated implantable accessories including the port plug (Model 7108) and lead anchor.
-
-