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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 Namepermanent pacemaker electrode
Generic Namepacemaker lead
Regulation Number870.3680
PMA NumberP950001
Supplement NumberS003
Date Received10/01/1997
Decision Date04/08/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: a) selute(r) picotip(tm) steroid eluting, endocardial pacing lead model 4030, 4031, 4032, 4033, 4034, and 4035 which are indicated for chronic pacing and asensing of the ventricle when used with a compatible pulse generator, and b) the use of the cosmed of illinois facility as an alternate sterilization site.