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Device | MEDTRONIC CAPSURE SP NOVUS MODEL 4092 VITATRON EXCELLENCE PS+ MODEL IMK 49B TRANVENOUS VENTRICULAR LEAD |
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 | P830061 |
Supplement Number | S030 |
Date Received | 05/24/1999 |
Decision Date | 06/16/1999 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a tine design change for the Model 4092 and IMK49B leads. |