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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
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.