• 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.
 
DeviceATLAS+ DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS, AND MODEL 3307 V.4.5A SOFTWARE
Classification Nameprogrammer, pacemaker
Generic Nameprogrammer, pacemaker
Regulation Number870.3700
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP830045
Supplement NumberS088
Date Received09/11/2003
Decision Date10/17/2003
Product Code
KRG[ Registered Establishments with KRG ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the epic+ icds to include higher energy output, software modifications, and a different header type. The device, as modified, will be marketed under the trade name atlas+ dr/vr implantable cardioverter defibrillators, models v-242, v-243, v-193 and v-193c, epic+ models v-233, v-239 and v196, and model 3307 v. 4. 5a software, and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Af suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above icd indications.
-
-