|
Device | VITATRON DIVA 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 | P990001 |
Supplement Number | S003 |
Date Received | 05/16/2000 |
Decision Date | 07/26/2000 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE PARYLENE COATED VERSION OF THE SELECTION AFM 902 PULSE GENERATOR AND THE MODEL VSA02, VERSION 6.0 PROGRAMMER SOFTWARE. |