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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.
 
DeviceCADENCE(R) TIERED THERAPY DEFIBRILLATOR SYSTEM
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP910023
Supplement NumberS030
Date Received09/08/1997
Decision Date02/02/1998
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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