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 ST LEAD MODELS 1888TC AND 1882TC |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S018 |
Date Received | 04/13/2006 |
Decision Date | 06/06/2006 |
Product Codes |
NVY NVZ |
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 TO MODIFY THE LEAD INSULATION ON THE TENDRIL ST 1788T/TC AND TENDRIL ST 1782 LEADS, AND TO REDUCE THE OUTER COIL WIRE DIAMETER ON THE TENDRIL ST 1782 LEAD. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES TENDRIL ST LEAD MODEL 1888TC AND TENDRIL ST LEAD MODEL 1882TC. THE TENDRIL ST LEAD MODEL 1888TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. THE TENDRIL ST LEAD MODEL 1882TC IS INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE RIGHT ATRIUM OR THE RIGHT VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR. |
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