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.
 
DeviceINTRATHECAL CATHETER AND REVISION KITS
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS136
Date Received07/08/2010
Decision Date12/15/2011
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE FOLLOWING MINOR DESIGN CHANGES: 1) MODEL 8709SC INDURA 1 PIECE INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR; 2) MODEL 8731SC INTRATHECAL CATHETER WITH SUTURELESS CONNECTOR; 3) MODEL 8596SC INTRATHECAL CATHETER PUMP SEGMENT REVISION KIT WITH SUTURELESS CONNECTOR; AND 4) MODEL 8578 SUTURELESS PUMP CONNECTOR REVISION KIT FOR MODEL 8709 AND MODEL 8709SC INTRATHECAL CATHETERS.
-
-