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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSWEET TIP(R) RX STEROID ELUTING LEAD
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Nametransvenous unipolar/bipolar pacing lead
ApplicantBOSTON SCIENTIFIC
PMA NumberP960006
Date Received03/04/1996
Decision Date10/02/1998
Product Code
NVN[ Registered Establishments with NVN ]
Docket Number 99M-1982
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the sweet tip(r) rx models 4143, 4144, 4145, 4243, 4244, and 4245 steroid-eluting, positive-fixation, porous tip, pacing leads. These devices are indicated for chronic pacing and sensing of the atrium and/or ventricle when used with a compatible pulse generator.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S007 
S008 S009 S010 S012 S013 S014 
S015 S016 S017 S019 S020 S021 
S022 S025 S026 S027 S029 S030 
S031 S032 S033 S034 S035 S036 
S037 S038 
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