FDA.reportPublic FDA data

PMA P970013S082

Device
Microny family of Pacemakers
Applicant
ABBOTT MEDICAL
Product code
LWO
Decision date
2020-06-30
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Approval order statement
Approval for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds; myMerlinPulse mobile application; Merlin PCS 3650 Programmer Software Model 3330 v25.0.1; and Merlin.net MN5000 v7.8.

Current openFDA PMA Record#

Device
Microny family of Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P970013
Supplement
S082
Product code
LWO
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Decision date
2020-06-30
Decision code
APPR
Date received
2019-11-08
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for Avant, Neutrino NxT, Gallant, and Entrant families of ICDs and CRT-Ds; myMerlinPulse mobile application; Merlin PCS 3650 Programmer Software Model 3330 v25.0.1; and Merlin.net MN5000 v7.8.