|
Device | VITATRON DIVA PLATFORM |
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 | P990001 |
Supplement Number | S005 |
Date Received | 11/08/2000 |
Decision Date | 01/08/2001 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN EXTENSION OF THE SHELF LIFE DATE TO 18 MONTHS FROM 12 MONTHS AND RELATED LABELING CHANGES. |