|
Device | MEDTRONIC SELECTSECURE LEAD MODEL 3830 |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P030036 |
Supplement Number | S002 |
Date Received | 09/07/2006 |
Decision Date | 10/11/2006 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A LABEL CHANGE TO THE TECHNICAL MANUAL FOR THE SELECTSECURE LEAD MODEL 3830. |