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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 pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS255
Date Received08/30/2010
Decision Date11/17/2011
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
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 Order Approval Order