• 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.
 
DeviceLINOX
Classification Namepermanent defibrillator electrodes
Generic Namepermanent defibrillator electrodes
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP980023
Supplement NumberS054
Date Received04/24/2013
Decision Date01/17/2014
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR AN ALTERNATE SUPPLIER FOR SHOCK COILS USED IN THE SUBJECT LEADS.
-
-