PMA P880086S338
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S338
- Product code
- DXY
- Decision date
- 2024-12-18
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- approval for the Merlin PCS Programmer Software Model 3330 v28.3.1 which includes device support and software updates
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S338
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2024-12-18
- Decision code
- APPR
- Date received
- 2024-09-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the Merlin PCS Programmer Software Model 3330 v28.3.1 which includes device support and software updates