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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 Namepacing lead
Regulation Number870.3680
PMA NumberP930039
Supplement NumberS009
Date Received03/13/2000
Decision Date08/31/2000
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
Recalls CDRH Recalls
Approval Order Statement 
Approval for an extendable/retractable screw-in pacing lead. The device, as modified, will be marketed under the trade names medtronic capsure(r)fix novus model 5076 and vitatron crystalline(r) actfix model icf09 pacing leads. These devices are indicated for permanent pacing and sensing of the ventricle and/or atrium when used with a compatible pule generator.