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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 NameMEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP850089
Supplement NumberS045
Date Received12/07/2000
Decision Date01/08/2001
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to distribute the medtronic(r) capsure(r) z novus models 5054 and 5554 pacing leads under a new trade name. The devices will be marketed under the trade name vitatron impluse ii models ihp 09b and ihp 09jb and are indicated for providing permanent pacing and sensing of the ventricle (model ihp 09b) and atrium (model ihp 09jb) when used with a compatible pulse generator.
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