|
Device | MEDTRONIC SELECTSECURE LEAD MODEL 3830 |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P030036 |
Supplement Number | S040 |
Date Received | 02/06/2012 |
Decision Date | 11/02/2012 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR IMPROVEMENTS TO THE SELECTSECURE MODEL 3830 LEAD DRUG METHODS AND SPECIFICATIONS. |