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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
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator (non-crt)
Applicant
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.
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