PMA P880086S324
- Device
- Assurity, Assurity+, Endurity, Endurity Core, Zenex and Zenus
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S324
- Product code
- DXY
- Decision date
- 2022-07-14
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- Second-tier supplier's manufacturing site transfer.
Current openFDA PMA Record#
- Device
- Assurity, Assurity+, Endurity, Endurity Core, Zenex and Zenus
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S324
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2022-07-14
- Decision code
- OK30
- Date received
- 2022-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Second-tier supplier's manufacturing site transfer.