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Device | CAPSURE Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED 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 | S038 |
Date Received | 11/03/1997 |
Decision Date | 06/01/1998 |
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 the addition of four transvenous leads to the CapSure(R) product line. The device, will be marketed under the trade names CapSure(R) Z Novus Models 5054 and 5554 and CapSure(R) SP Novus Models 5092 and 5592 and are indicated for pacing and sensing in the atrium or ventricle where implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated. |