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.
 
DeviceMEDTRONIC MODEL 8516 PERCUTANEOUS INTRASPINAL CATHETER KIT
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS068
Date Received02/07/2005
Decision Date03/10/2005
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeSpecial (Immediate 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 A TECHNICAL MANUAL ADDENDUM TO BE ADDED TO THE PACKAGED CATHETER KIT TO STRENGTHEN THE INSTRUCTIONS FOR THE PROPER USE OF THE CONNECTOR.
-
-