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

Devices@FDA
  • Print
  • Share
  • E-mail
-
 
Help | Download Files | More about PMA

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.
 
DeviceSynchroMed® Infusion System, Ascenda® Intrathecal Catheters
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS424
Date Received01/29/2024
Decision Date04/09/2024
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
approval for a minor design change to a Radio Frequency (RF) PIN Diode of the Telemetry-M (Tel-M) communication circuit and consequent minor change to the Printed Circuit Board (PCB) used on the Intellis 8880T2 (Clinician Telemetry Module, CTM2), 97745 / 97745FA (Programmer Patient Therapy Manager, PTM3), and 97745NT (Programmer Patient Therapy Manager, PTM3 No Bluetooth)
  We welcome your comments and feedback about Devices@FDA.
-
-