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 | CARELINK MONITOR & CARDIOSIGHT READER |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S169 |
Date Received | 03/06/2009 |
Decision Date | 04/04/2011 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE ADVISA DR A4DR01 IMPLANTABLE PULSE GENERATOR, MODEL 9995 APPLICATION SOFTWARE V7.3, CARELINK MONITOR MODEL 2490G UPGRADE, CARDIOSIGHT READER MODEL 2020A UPGRADE, AND MODEL 2491 DDMA UPGRADE. |
Approval Order | Approval Order |
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