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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.
 
Trade NameINCEPTA, ENERGEN, PUNCTUA AND TELIGEN ICDS
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namecardiac resynchronization therapy defibrillator (crt-d) system
ApplicantBOSTON SCIENTIFIC-CRM
PMA NumberP960040
Supplement NumberS235
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 - other
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Recalls CDRH 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 arrhythmias or 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
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