PMA P880086S325
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S325
- Product code
- DXY
- Decision date
- 2022-09-30
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for the Merlin@home transmitter software model EX2000 v9.0 and cybersecurity enhancements.
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S325
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- 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.