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.
 
DeviceLEGEND PLUS FAMILY OF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantMEDTRONIC Inc.
8200 Coral Sea Street NE
Mounds View, MN 55112
PMA NumberP930022
Supplement NumberS010
Date Received06/17/2009
Decision Date07/28/2009
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
-
-