|
Device | INSYNC/INSYNC III CRT-IPGS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S018 |
Date Received | 12/08/2005 |
Decision Date | 12/22/2005 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR SOFTWARE ENHANCEMENTS TO THE MODEL 9986 DESKTOP/BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8 AND 1.5 FOR THE MEDTRONIC MODEL 2090 CARELINK PROGRAMMER. |