• 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 NameALERT SYSTEM-COMPANION II
Classification Namesystem,pacing,temporary,acute,internal atrial defibrillation
ApplicantDOT MEDICAL PRODUCTS LTD.
PMA NumberP990069
Supplement NumberS001
Date Received04/28/2003
Decision Date09/29/2003
Product Code
MTE[ Registered Establishments with MTE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the alert system, companion ii. The device, as modified, is indicated for use in patients who are candidates for transvenous electrical cardioversion for the treatment of atrial fibrillation.
-
-