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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC MODEL 5038 CAPSURE VDD-2 LEAD
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP890003
Supplement NumberS050
Date Received05/05/1997
Decision Date06/03/1998
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for new pacing lead models. The devices, as modified, will be marketed under the trade names: Medtronic Models 5038-58, 5038-65, 5038-52, 5038S-58, and 5038L-65 CapSure VDd-2 and Vitatron Models IMW 14Q/15Q/16Q/17Q/18Q Brilliant S+ VDD Pacing Leads and are indicated for bipolar sensing in the atrium and bipolar sensing and pacing in the ventricle when used with current Medtronic(R) VDD pacemakers.
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