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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.
 
DeviceSWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
Applicant
BOSTON SCIENTIFIC
4100 hamline avenue north
st. paul, MN 55112
PMA NumberP960006
Supplement NumberS001
Date Received10/02/1998
Decision Date04/09/1999
Product Code
DTB[ Registered Establishments with DTB ]
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 several new lead models: the sweet picotip(tm) rx models 4050, 4051, 4052, 4053, 4054, and 4055 steroid eluting, positive-fixation, porous tip pacing leads. These devices are indicated for chornic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
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