|
Device | MARQUIS DR/VR 7274/7230 ICD |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S150 |
Date Received | 08/20/2008 |
Decision Date | 10/24/2008 |
Product Code |
LWS |
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 1.1, RVLIA SOFTWARE. |