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 | EVERA S DR ICD, S VR ICD,XT DR ICD, XT VR ICD, INTRINISIC ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, MAXIMO II ICD; 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 | S417 |
Date Received | 05/17/2013 |
Decision Date | 07/23/2013 |
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 FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS. |
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