PMA P880086S279
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S279
- Product code
- DXY
- Decision date
- 2017-10-20
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for Merlin.net MN5000 v7.5 Software to add support for the Confirm Rx Insertable Cardiac Monitor.
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S279
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2017-10-20
- Decision code
- APPR
- Date received
- 2017-02-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Merlin.net MN5000 v7.5 Software to add support for the Confirm Rx Insertable Cardiac Monitor.