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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 NumberS230
Date Received12/11/2009
Decision Date09/16/2010
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 11M-0034
Notice Date 01/25/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00180271
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for a modification to the indications for use for the cognis crt-d models n118, n119; liviancrt-d models h220, h225, h227 and h229; and contak renewal 3 rf he crt-d modelsh210, h215, h217, h219 cardiac resynchronization therapy defibrillators (crt-ds) as follows:these boston scientific cardiac resynchronization therapy defibrillators (crt-ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (opt) for heart failure and who meet any one of the following classifications:1) moderate to severe heart failure (nyha class iii-iv) with ef <= 35% and qrs duration>= 120 ms; or2) left bundle branch block (lbbb) with qrs >= 130 ms, ef <= 30%, and mild (nyhaclass ii) ischemic or nonischemic heart failure or asymptomatic (nyha class i)ischemic heart failure.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress