|
Device | CARELINK MONITOR MODELS 2490G, 2490H, 2490J, AND THE 2020A CARDIOSIGHT READER |
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 | S071 |
Date Received | 12/01/2006 |
Decision Date | 09/14/2007 |
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 A MANUFACTURING SITE LOCATED AT PLEXUS SERVICES CORP., PENANG, MALAYSIA. |