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.
 
DevicePain RC Spinal Cord Stimulation System (SCS) System
Generic NameStimulator, spinal-cord, totally implanted for pain relief
ApplicantMEDTRONIC NEUROMODULATION
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432
PMA NumberP840001
Supplement NumberS527
Date Received08/29/2022
Decision Date01/08/2024
Product Code LGW 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the following: For P960009/S438, approval for: • Model B35300 Percept RC Implantable Neurostimulator (INS)• Model RS6230 Recharger Kit (including the WR9230 Recharger)• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) • Model A620 Patient Programmer Application (CPA) (Version 3.0) • A90300 Recharger Application Software (RAS) (Version 2.0) • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC System.For H020007/S329, approval for: • Model B35300 Percept RC Implantable Neurostimulator (INS)• Model RS6230 Recharger Kit (including the WR9230 Recharger)• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) • Model A620 Patient Programmer Application (CPA) (Version 3.0) • A90300 Recharger Application Software (RAS) (Version 2.0) • Dystonia Kits (Models 33TH60, 33TH76, and 33TH69) • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC System.For H050003/S289, approval for:• Model A610 Clinician Programmer Application (PPA) Software (Version 4.0) For P840001/S527, approval for: • Labeling changes in physician and patient labeling for existing products, to be consistent with the proposed labeling for the new Percept RC System
-
-