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 | TENDRIL SDX |
Generic Name | permanent pacemaker Electrode |
Regulation Number | 870.3680 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S007 |
Date Received | 09/13/1999 |
Decision Date | 03/07/2000 |
Product Code |
DTB |
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 Tendril SDX Model 1488/K/TC endocardial, steroid-eluting, active-fixation pacing leads. |
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