PMA P880086S322
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers.
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S322
- Product code
- DXY
- Decision date
- 2022-01-07
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for Merlin PCS 3650 Programmer Model 3330 Software v25.41.
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, Endurity, Accent family of Pacemakers.
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S322
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2022-01-07
- Decision code
- APPR
- Date received
- 2021-10-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Merlin PCS 3650 Programmer Model 3330 Software v25.41.