|
Device | CONCERTO/INSYNC SENTRY/INSYNC MAXIMO |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S104 |
Date Received | 06/09/2008 |
Decision Date | 08/28/2008 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE RV LEAD INTEGRITY ALERT (RVLIA) FEATURE AND MODEL SW012, VERSION 1.0, RVLIA SOFTWARE. |
Post-Approval Study | Show Report Schedule and Study Progress |