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. |
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Device | CAPSURE Z MODELS 5034/5534/5033 PACING LEADS |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P850089 |
Supplement Number | S033 |
Date Received | 04/06/1995 |
Decision Date | 12/21/1995 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODELS 5034, 5534, 5033 PACING LEADS - THE DEVICES AS MODIFIED WILL BE MARKETED UNDER THE TRADE NAMES CAPSURE Z MODEL 5-34, 5534, AND 5033 PACING LEADSAND HAVE APPLICATIONS WHERE PERMANENT VENTRICULAR, ATRIAL, OR DUAL CHAMBERED PACING SYSTEMS ARE INDICATED. THE LEADS ARE USED TO PROVIDE CHANNELED, ELECTRICALLY CONDUCTIVE PATHWASY BETWEEN THE PULSE GENERATOR AND THE HEART |
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