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 | ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-P'S |
Generic Name | pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p) |
Applicant | Abbott Medical 15900 valley view court sylmar, CA 91335 |
PMA Number | P030035 |
Supplement Number | S147 |
Date Received | 04/26/2016 |
Decision Date | 07/25/2016 |
Product Code |
NKE |
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 software modifications to the Merlin.net MN6000 HF Web Application v9.0 software. |
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