|
Device | MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P950024 |
Supplement Number | S002 |
Date Received | 07/01/1998 |
Decision Date | 09/16/1999 |
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 a new pacing lead model and is indicated for use with a pulse generator as part of a cardiac pacing system. The lead has application where implantable epicardial atrial or ventricular, single or dual chamber pacing systems are indicated. |
Post-Approval Study | Show Report Schedule and Study Progress |