PMA P880086S293
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S293
- Product code
- DXY
- Decision date
- 2018-04-11
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for cybersecurity updates and implementation of a Battery Performance Alert in the firmware of ICDs and CRT-Ds.
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S293
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2018-04-11
- Decision code
- APPR
- Date received
- 2018-01-18
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for cybersecurity updates and implementation of a Battery Performance Alert in the firmware of ICDs and CRT-Ds.