PMA P970013S089

Device
Microny family of Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P970013
Supplement
S089
Product code
LWO
Decision date
2022-01-07
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Approval order statement
Approval for Merlin PCS 3650 Programmer Model 3330 Software v25.41.

Current openFDA PMA Record#

Device
Microny family of Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P970013
Supplement
S089
Product code
LWO
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Decision date
2022-01-07
Decision code
APPR
Date received
2021-10-18
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for Merlin PCS 3650 Programmer Model 3330 Software v25.41.