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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
St. Jude Medical
15900 valley view ct.
sylmar, CA 91342-3577
PMA NumberP910023
Supplement NumberS030
Date Received09/08/1997
Decision Date02/02/1998
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
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.