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 |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | GUIDANT CORP. 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P030005 |
Supplement Number | S003 |
Date Received | 06/21/2004 |
Decision Date | 08/06/2004 |
Product Code |
DTB |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR PROGRAMMER SOFTWARE APPLICATION MODEL 2865 VERSION 1.9. |
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