• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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.
 
Trade NameCAPSURE EPICARDIAL PACING LEAD
Classification Namepermanent defibrillator electrodes
Generic Namecapsure epi epicardial steroid eluting pacing lead
Applicant MEDTRONIC INC.
PMA NumberP950024
Supplement NumberS039
Date Received11/25/2011
Decision Date12/19/2011
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a new vision system equipment controller (ec) fixture system as part of the sterile pack process.
-
-