• 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 NameVENTAK MINI HE AND VENTAK MINI III AICD TM SYSTEMS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP910077
Supplement NumberS022
Date Received07/28/1997
Decision Date01/23/1998
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for higher shock energy for the ventak mini he, the downsized ventak mini iii, revisions to the ventak mini application software-model 2840, and labeling revisions ot indicate shock energy as joules "stored" and updating the indications for use.
-
-