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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
Classification Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Generic Namedrug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
4100 hamline avenue north
st. paul, MN 55112
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 S039 S040 S041 S042 
S043 S044 S046