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. |
|
Device | CARELINK MONITOR MODELS 2490G/2491DDMA |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S189 |
Date Received | 03/31/2010 |
Decision Date | 03/22/2011 |
Product Code |
NKE |
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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE CONSULTA CRT-P C4TR01 AND SYNCRA CRT-P C2TR01 IMPLANTABLE PULSE GENERATORS WITH CARDIAC RESYNCHRONIZATION, SOFTWARE MODEL 9995 (VERSION 7.3), CARELINK MONITOR MODELS 2490G AND MODEL 2491 DDMA. |
Approval Order | Approval Order |
|
|