Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VIRTUOSO II ICD DR/VR |
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 | S157 |
Date Received | 09/24/2008 |
Decision Date | 10/23/2008 |
Product Code |
LWS |
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 TO IMPLEMENT A DESIGN CHANGE TO ADD THREE NEW"INTERMEDIATE-FEATURE" MODELS (CONCERTO II MODEL CRT-D D274TRK. VIRTUOSO II ICD MODEL DRD274DRG AND MODEL VR D274VRC) TO THE APPROVED GEN 2 CONSULTA/SECURA/ MAXIMA II FAMILYOF DEVICES (CONSULTA CRT-D D224TRK, MAXIMO II CRT-D D284TRK. SECURE VR D224VRC,MAXIMO II DR D284DRG, AND MAXIMO II D284 VRC SUBMITTED UNDER P01003I/S084 ANDP980016/S114, APPROVED MARCH 17, 2008). |
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