PMA P880086S306
- Device
- Assurity, Endurity Core Family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- Product code
- DXY
- Decision date
- 2020-05-13
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Approval for a design and supplier change of the moisture getter.
Current openFDA PMA Record#
- Device
- Assurity, Endurity Core Family of Pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S306
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2020-05-13
- Decision code
- APPR
- Date received
- 2019-10-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design and supplier change of the moisture getter.