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Device | RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS |
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 | S053 |
Date Received | 07/29/2005 |
Decision Date | 08/19/2005 |
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 THE RAMWARE (BASELINE 15 WITH INC5 RAMWARE) UPDATE TO THE MEDTRONIC ENTRUST 30J/35J ICD SYSTEMS FOR THE FOLLOWING MODELS: MEDTRONIC ENTRUST MODEL D153ATG;MEDTRONIC ENTRUST MODEL D153DRG;MEDTRONIC ENTRUST MODEL D153VRC;MEDTRONIC ENTRUST MODEL D154ATG;MEDTRONIC ENTRUST MODEL D154DRG; ANDMEDTRONIC ENTRUST MODEL D154VRC. |