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 LEADS MODELS 1788 & 1782 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S033 |
Date Received | 05/11/2007 |
Decision Date | 06/26/2007 |
Product Code |
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 FOR RING ELECTRODE MODIFICATIONS TO TENDRIL 1788 AND 1782 LEADS, AND AN OUTER INSULATION TUBE DIAMETER CHANGE FOR TENDRIL 1782 LEADS. |
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