PMA P970013S081

Device
Microny family of Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P970013
Supplement
S081
Product code
LWO
Decision date
2019-12-23
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Approval order statement
Approval for changes to Merlin PCS 3650 Programmer Model 3330 Software.

Current openFDA PMA Record#

Device
Microny family of Pacemakers
Applicant
ABBOTT MEDICAL
PMA number
P970013
Supplement
S081
Product code
LWO
Generic name
Pulse-generator, single chamber, sensor driven, implantable
Decision date
2019-12-23
Decision code
APPR
Date received
2019-10-30
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to Merlin PCS 3650 Programmer Model 3330 Software.