|
Device | MEDTRONIC KAPPA 700/600 PACING SYSTEM WITH MODEL 9953 - SERIES 1.1 SOFTWARE |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S009 |
Date Received | 02/08/2001 |
Decision Date | 03/08/2001 |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE KAPPA 650 SERIES PULSE GENERATORS AND VISION SOFTWARE SERIES 4.0. |