|
Device | EPG-SINGLE AND DUAL CHAMBER |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P820003 |
Supplement Number | S114 |
Date Received | 11/25/2011 |
Decision Date | 12/21/2011 |
Product Code |
LWP |
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 COMPONENTS CHANGING FROM LEAD-CONTAINING TO LEAD-FREE USED IN THE MEDTRONIC 2090 PROGRAMMER, 5388 DUAL CHAMBER EPG, AND 5348 SINGLE CHAMBER EPG. |