PMA P970013S090

Device: Microny family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P970013
Supplement: S090
Product code: LWO
Decision date: 2022-05-17
Generic name: Pulse-generator, single chamber, sensor driven, implantable
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.

Current openFDA PMA Record#

Device: Microny family of Pacemakers
Applicant: ABBOTT MEDICAL
PMA number: P970013
Supplement: S090
Product code: LWO
Generic name: Pulse-generator, single chamber, sensor driven, implantable
Decision date: 2022-05-17
Decision code: APPR
Date received: 2022-03-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.