PMA P970013S087

Device
Microny family of Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P970013
Supplement
S087
Product code
LWO
Decision date
2021-06-28
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Approval order statement
Approval for changes to the Merlin PCS 3650 Programmer Model 3330 Software to create v25.1.1.

Current openFDA PMA Record#

Device
Microny family of Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P970013
Supplement
S087
Product code
LWO
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Decision date
2021-06-28
Decision code
APPR
Date received
2021-04-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to the Merlin PCS 3650 Programmer Model 3330 Software to create v25.1.1.