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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.
 
DeviceINCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantBOSTON SCIENTIFIC
4100 Hamline Avenue North
St. Paul, MN 55112
PMA NumberP960040
Supplement NumberS235
Date Received08/30/2010
Decision Date11/17/2011
Product Code LWP 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR INCEPTA, ENERGEN. PUNCTUA AND TELIGEN ICD MODELS AND THE INCEPTA, ENERGEN. PUNCTUA AND COGNIS CRT-D MODELS AND PRM SOFTWARE APPLICATION MODEL 2868 AND PULSE GENERATOR SOFTWARE. THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS ICD AND CRT-D MODELS AND ARE INDICATED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIASOR FOR PATIENTS WITH HEART FAILURE WHO RECEIVE STABLE OPTIMAL PHARMACOLOGICAL THERAPY: MODERATE TO SEVERE HEART FAILURE (NYHA CLASS I1I-IV) WITH EF <= 35% AND QRS DURATION >= 120 MS AND LEFT BUNDLE BRANCH BLOCK (LBBB) WITH QRS >= 130 MS, EF <= 30%, AND MILD (NYHA CLASS II) ISCHEMIC OR NONISCHEMIC HEART FAILURE OR ASYMPTOMATIC (NYHA CLASS 1) ISCHEMIC HEART FAILURE.
Approval OrderApproval Order
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