• 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 NameCADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
Classification Nameimplantable cardioverter defibrillator (non-crt)
ApplicantVENTRITEX, INC.
PMA NumberP910023
Supplement NumberS030
Date Received09/08/1997
Decision Date02/02/1998
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 the contour(tm) ii/angstrom(tm) ii implantable cardioverter/defibrillator (icd) system (contour(tm) ii icd models v-185, v-185b, v-185c, v-185d and v-185ac, angstrom(tm) ii icd models v-180f and v-180hv3, torque drive model ac-td, df-1 receptacle plug model ac-dp and programmer software version 5. 1), a modification to programmer software version 5. 1 to allow use with the ventritex(r) programmer model pr-1500, use of the contour(tm) ii and angstrom(tm) ii pulse generator with the medtronic(r) transvene(r) leads, changes in the contour(tm) ii/angstrom(tm) ii labeling and modifications to programmer software version 5. 1 to improve the ecg display and theaccuracy of the reported data.
-
-