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 AND OPTISENSE LEAD FAMILIES |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P960013 |
Supplement Number | S071 |
Date Received | 02/14/2012 |
Decision Date | 04/13/2012 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MODIFICATION TO THE CONNECTOR BOOT ON THE ISOFLEX TENDRIL ST, TENDRIL STS, AND OPTISENSE LEAD MODELS, TENDRIL ST MODELS 1882, 1888, TENDRIL STS MODELS 1988, 2088 AND OPTISENSE MODEL 1999. |
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