|
Device | MEDTRONIC MODEL 5719 ACTIVE CAN EMULATOR (ACE) PRODUCT |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P900061 |
Supplement Number | S054 |
Date Received | 12/18/2002 |
Decision Date | 01/06/2003 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING AND PACKAGING FACILITY LOCATED AT MEDTRONIC ARIZONA DEVICE MANUFACTURING, TEMPE, ARIZONA. |