|
Device | CAPSURE EPI PACING LEADS |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P950024 |
Supplement Number | S040 |
Date Received | 12/09/2011 |
Decision Date | 11/27/2012 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL TO ADD MODEL 4965 POST-APPROVAL STUDY RESULTS TO THE DEVICE LABELING. |
Post-Approval Study | Show Report Schedule and Study Progress |