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 | VARIOUS MODELS OF PACEMAKERS, MODELS SYMBIOS, SYNERGYST,SPECTRAX,PASYS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P820003 |
Supplement Number | S076 |
Date Received | 12/09/2005 |
Decision Date | 05/12/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEDTRONIC MODEL 2091 WB WIRELESS PC CARD FOR USE WITH MEDTRONIC MODEL 9986 DESKTOP/BOSS (SW VERSION 1.5) FOR THE MEDTRONIC CARELINK PROGRAMMER (MODEL 2090) FOR ALL MEDTRONIC AND VITATRON PACEMAKER AND ICD MODELS. |
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