|
Device | SYMPHONY & ELA RHAPSODY PACEMAKERS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S021 |
Date Received | 10/07/2004 |
Decision Date | 10/27/2004 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE LABELING FOR THE SYMPHONY AND ELA RHAPSODY PACEMAKERS TO INCLUDE INSTRUCTIONS ABOUT TESTING, SENSING OR PACING WHILE THE PACEMAKER IS OUT OF THE POCKET. |