|
Device | VITATRON T-SERIES SOFTWARE MODEL VSF07/08, VSE03/04 |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P990001 |
Supplement Number | S019 |
Date Received | 05/18/2005 |
Decision Date | 09/21/2005 |
Product Code |
NVY |
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 CHANGES TO THE CALIBRATOR AND CONTROL RECOVERY RANGES. |