|
Device | MEDTRONIC SIGMA PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S029 |
Date Received | 05/12/2003 |
Decision Date | 06/06/2003 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE CONNECTOR IN THE SIGMA AND 350 SERIES PACEMAKERS TO IMPROVE YIELD AND MANUFACTURABILITY. |