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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 NameSWEET PICOTIP(TM) RX STEROID ELUTING, POROUS TIP, POSITIVE FIXATION LEAD
Classification Namepermanent pacemaker electrode
Generic Nametransvenous unipolar/bipolar pacing lead
Regulation Number870.3680
ApplicantGUIDANT CORP.
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 - component
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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