• 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 SCS IPG, Infinity DBS IPG, Proclaim DRG IPG
Generic Namestimulator, spinal-cord, totally implanted for pain relief
Applicant
Abbott Medical
6901 preston road
plano, TX 75024
PMA NumberP010032
Supplement NumberS158
Date Received12/13/2019
Decision Date01/10/2020
Product Code LGW 
Advisory Committee Neurology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate Tier II supplier of the crystal used in the Orion family IPG devices.
-
-