|
Device | MEDTRONIC INTRINSIC MODELS 7287 AND 7288 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 | S043 |
Date Received | 07/07/2004 |
Decision Date | 08/18/2004 |
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 A RAMWARE UPDATE TO THE MEDTRONIC INTRINSIC MODELS 7287 AND 7288 ICD SYSTEMS. |