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 | Allure, Allure Quadra, and Quadra Allure MP |
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 | S181 |
Date Received | 04/24/2020 |
Decision Date | 05/21/2020 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Implementation of an automated system, Vaisala EMS, for process monitoring to replace existing chart recorders and electronic monitoring systems at the Abbott/St. Jude Medical Scottsdale, Arizona component manufacturing site. |
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