|
Device | Microny family of Pacemakers |
Generic Name | Pulse-generator, single chamber, sensor driven, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P970013 |
Supplement Number | S090 |
Date Received | 03/07/2022 |
Decision Date | 05/17/2022 |
Product Code |
LWO |
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 Merlin Patient Care System (PCS) 3650 Model 3330 v25.8.1 software andMerlin 2 PCS Model MER3400 vl.8.1 software to improve the accuracy of the remaining battery longevity estimate by the programmer. |