PMA P880086S341
- Device
- Assurity, Assurity +, Endurity, Endurity Core, Endurity, Endurity Core, Zenus, Zenex
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S341
- Product code
- DXY
- Decision date
- 2024-12-19
- Classification
- Cardiovascular
- Generic name
- implantable pacemaker Pulse-generator
- Approval order statement
- to update electrical/ and software tests performed during manufacturing of pulse generators
Current openFDA PMA Record#
- Device
- Assurity, Assurity +, Endurity, Endurity Core, Endurity, Endurity Core, Zenus, Zenex
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S341
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2024-12-19
- Decision code
- OK30
- Date received
- 2024-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to update electrical/ and software tests performed during manufacturing of pulse generators