• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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.
 
Trade NameOVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
ApplicantELA MEDICAL, INC.
PMA NumberP980049
Supplement NumberS020
Date Received04/29/2005
Decision Date04/28/2006
Product Code
MRM[ Registered Establishments with MRM ]
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 an implantable cardioverter defibrillator (icd) that combines features of the alto 2 dr 624, alto 2 vr 625 icds, and symphony 2550 pacemaker, including reduced size, modified shock circuitry and other changes. The device will be marketed under the trade name ovatio dr model 6550 and ovatio vr model 6250 icds, elaview 1. 32 ug2 programming software and cpr3 programming head with hso 2. 76 software and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: 1) survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, 2) recurrent, poorly tolerated sustained ventricular tachycardia (vt). Note: the clinical outcome for hemodynamically stable vt patients is not fully known. Safety and effectiveness studies have not been conducted.
Post-Approval StudyShow Report Schedule and Study Progress
-
-