|
Device | INSYNC III |
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 | S022 |
Date Received | 02/21/2006 |
Decision Date | 04/21/2006 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE SESSIONSYNC FEATURE AS PART OF AN ENHANCEMENT TO MODEL 9986 DESKTOP / BASELINE OPERATING SYSTEM SOFTWARE (BOSS) VERSIONS 1.3.8/1.5 FOR THE 2090 CARELINK PROGRAMMER. SESSIONSYNC ALLOWS DATA TRANSFER BETWEEN THE MODEL 2090 CARELINK PROGRAMMER AND THE CUSTOMER'S PACEART SYSTEM (A DATA MANAGEMENT SYSTEM). |
Post-Approval Study | Show Report Schedule and Study Progress |