PMA P880086S304
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S304
- Product code
- DXY
- Decision date
- 2019-03-13
- Classification
- Implantable Pacemaker Pulse-generator
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for software modification to the Merlin.net MN6000 HF Web Application v10.0 software.
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S304
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2019-03-13
- Decision code
- APPR
- Date received
- 2018-10-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software modification to the Merlin.net MN6000 HF Web Application v10.0 software.