• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
Generic Namedrug eluting permanent left ventricular (lv) pacemaker electrode
8200 coral sea street ne
ms mv s11
mounds view, MN 55112
PMA NumberP010015
Supplement NumberS107
Date Received01/04/2011
Decision Date05/13/2011
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
Approval for the medtronic model 9986 desktop/ boss version 2. 4 for use on the medtronic model 2090 carelink programmer.
Approval Order Approval Order