|
Device | CAPSURE SP NOVUS LEAD MODEL 5594 |
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 | S046 |
Date Received | 05/21/2001 |
Decision Date | 06/14/2001 |
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 CAPSURE SP NOVUS LEAD MODEL 5594. THE DEVICE IS INDICATED FOR PACING AN DSENSING IN THE ATRIUM. THE LEAD HAS APPLICATIONS WHERE IMPLANTABLE ATRIAL SINGLE-CHAMBER OR DUAL-CHAMBER PACING SYSTEMS ARE INDICATED. |