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 | CONTAK RENEWAL TR CRT-P SYSTEM |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P030005 |
Supplement Number | S046 |
Date Received | 08/23/2007 |
Decision Date | 12/20/2007 |
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 |
Approval Order Statement APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM. |
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