PMA P880086S311
- Device
- Endurity, Endurity Core, and Assurity pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S311
- Product code
- DXY
- Decision date
- 2020-01-06
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Qualify a vendor for ceramic material used to in the Scalable Brady Pacers Filtered Feedthroughs.
Current openFDA PMA Record#
- Device
- Endurity, Endurity Core, and Assurity pacemakers
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S311
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2020-01-06
- Decision code
- OK30
- Date received
- 2019-12-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualify a vendor for ceramic material used to in the Scalable Brady Pacers Filtered Feedthroughs.