PMA P970013S091
- Device
- Microny family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S091
- Product code
- LWO
- Decision date
- 2022-09-30
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Approval order statement
- Approval for the Merlin@home transmitter software model EX2000 v9.0 and cybersecurity enhancements.
Current openFDA PMA Record#
- Device
- Microny family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P970013
- Supplement
- S091
- Product code
- LWO
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Decision date
- 2022-09-30
- Decision code
- APPR
- Date received
- 2022-07-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Merlin@home transmitter software model EX2000 v9.0 and cybersecurity enhancements.